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Adverse Event Report

COOPERSURGICAL, INC. HUMI (HARRIS-KRONNER UTERINE MANIPULATORY-INJECT) UTERINE MANIPULATOR-INJECTOR   back to search results
Model Number 6001
Event Type  Malfunction   Patient Outcome  Other;
Event Description

"or" supervisor notified mfr that two (2) 6001 humi's had broken at the spring. No pt injury.

 
Manufacturer Narrative

Samples of harris-kronner uterine manipulator/injector, (humi), p/n 6001, lot 90729d, were received and tested by qual. Assurance with the aide of mfg engr. As needed. Upon inspection, no evidence of product or mfg defect was found. The company was not able to reproduce the tip breakage experienced at the user facility. Also, there is no indication of problem in the lot device history documentation. Reporting incident per 3/2001 fda audit direction.

 
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Brand NameHUMI (HARRIS-KRONNER UTERINE MANIPULATORY-INJECT)
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
thomas williams, dir.
15 forest parkway
shelton , CT 06484
(203) 929 -6321
Device Event Key316919
MDR Report Key327536
Event Key308231
Report Number1216677-2001-00002
Device Sequence Number1
Product CodeLKF
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 04/11/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2002
Device MODEL Number6001
Device Catalogue Number6001
Device LOT Number90729D
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/29/2000
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/1999
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 December 31, 2008

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