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Adverse Event Report

CODMAN & SHURTLEFF, INC. CUSTOM DEVICE-MURPHY BALL PROBE   back to search results
Catalog Number SP-1284-2
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Visual examination of the returned customer device murphy ball probe found the tip missing and the shank of the instrument twiested. This damage is indicative of the application of forces that were greater than those intended for this item. Review of processing and mfg records found the processing of the device met specification requirements. The cause of the failure cannot be positively determined as the tip of the instrument was not returned, however, the observed damage appears to be related to user handling of the device. At this time, the complaint is considered to be closed.

 
Manufacturer Narrative

See h10.

 
Event Description

Customer returned a custom device murphy ball probe requesting repair or replacement. Customer was contacted and it was learned that the ball portion of the instrument broke off and is missing. Customer reports it may have fallen into a patient.

 
Manufacturer Narrative

The device has been returned for evaluation. Results will be forwarded to the fda upon completion of the evaluation.

 
Search Alerts/Recalls

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Brand NameCUSTOM DEVICE-MURPHY BALL PROBE
Type of DevicePROBE
Baseline Brand NameCUSTOM DEVICE - MURPHY BALL PROBE
Baseline Generic NamePROBE
Baseline Catalogue NumberSP-1284-2
Baseline Device FamilyCUSTOM DEVICE - MURPHY BALL PROBE
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Shelf Life(Months)NA
Date First Marketed06/01/1995
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham MA 02767
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham MA 02767
Manufacturer Contact
matthew king
325 paramount drive
raynham , MA 02767
(508) 828 -3106
Device Event Key391368
MDR Report Key402349
Event Key380247
Report Number1226348-2002-00111
Device Sequence Number1
Product CodeHXB
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation UNKNOWN
Type of Report Initial,Followup
Report Date 06/05/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSP-1284-2
Device LOT Number6/1995
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/05/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1995
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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