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Adverse Event Report

COOPERSURGICAL, INC. HUMI (HARRIS UTERINE MANIPULATOR-INJECTOR   back to search results
Model Number 6001
Event Date 01/11/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Distributor notified the mfr of a malfunction of a uterine manipulator. It was stated that the tubing broke inside the pt. Intervention by surgical technique was required to recover the broken piece.

 
Manufacturer Narrative

Two samples were returned by the distributor for review and confirmation of the stated malfunction. These units were reviewed on 01/17/2000 and one of the two was found to be broken at the 7cm section of the device. The break does not appear to be consistent with a failure mode expectation. The second sample appears to have been manipulated beyond the intended purpose. The mfr initiated several telephone calls to obtain further detail. One conversation on 01/31/2000 indicated that the pt did not suffer permanent damage and that the hosp staff would be apprised of the event on 02/01/2000. Follow up message to the hosp delivered 02/04/2000. Note: previously reported errantly with on-line system. Re-submitted per request on mandatory report.

 
Manufacturer Narrative

User facility initially reported surgical technique was required to remove the broken portion of the humi (a single 1" to 3" piece). This information was incorrect. The broken portion was removed trans-vaginally with forceps. Addition mfr narrative: corrective action was taken january 2001, to increase customer satisfaction. The rare occurrences of this fmea identified, non-adverse failure type have been reduced by increasing the extrudiate wall thickness.

 
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Brand NameHUMI (HARRIS UTERINE MANIPULATOR-INJECTOR
Type of DeviceUTERINE MANIPULATOR-INJECTOR
Baseline Brand NameHUMI
Baseline Generic NameHARRIS UTERINE MANIPULATOR-INJECTOR
Baseline Catalogue Number6001
Baseline Model Number6001
Baseline Device FamilyUTERINE MANIPULATORS
Baseline Device 510(K) NumberK770727
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed04/25/1997
Manufacturer (Section F)
COOPERSURGICAL, INC.
15 forest pkwy.
shelton CT 06484
Manufacturer (Section D)
COOPERSURGICAL, INC.
15 forest pkwy.
shelton CT 06484
Manufacturer Contact
tom williams
15 forest pkwy
shelton , CT 06484
(203) 929 -6321
Device Event Key257961
MDR Report Key266466
Event Key249778
Report Number1216677-2000-00001
Device Sequence Number1
Product CodeLKF
Report Source Manufacturer
Source Type User facility,Distributor
Reporter Occupation Other
Remedial Action Replace,Other
Type of Report Initial,Followup
Report Date 02/29/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2001
Device MODEL Number6001
Device Catalogue Number6001
Device LOT Number81021D
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/17/2000
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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