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Adverse Event Report

CONMED CORPORATION REFLEX ELC ENDOSCOPIC CLIP APPLIER   back to search results
Catalog Number 530
Event Date 01/08/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that, "during a laparoscopic cholecystectomy, the hepatic artery was severed by the jaws of the endoscopic clip applier, when the clips failed to feed through the device. An open procedure was needed to repair the injury and complete the procedure. The patient had an uneventful recovery. ".

 
Manufacturer Narrative

The device may have been made by imagyn surgical prior to the acquisition of imagyn by conmed corporation. The lot code was not reported, however the logo on the device was the imagyn logo. Conmed has assumed reporting for these devices since the acquisition on 7/2001. The device has been received and decontaminated but the investigation has not been completed. When the investigation is finished, co will file a supplemental report.

 
Manufacturer Narrative

The returned device was examined by a mfg engineer. He was unable to determine if the device had been made by imagyn surgical prior to their acquisition by conmed, as no lot code was reported. Conmed assumed reporting responsibility for these devices with the acquisition on 07/06/01. He was able to determine that the clips were jammed and did not feed through the device. If the surgeon had followed the directions for use (a copy is included as page 3 of 3), the artery would not have been severed. They have highlighted the pertinent areas. Co feels this investigation has been completed and the complaint closed.

 
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Brand NameREFLEX ELC
Type of DeviceENDOSCOPIC CLIP APPLIER
Baseline Brand NameREFLEX ELC
Baseline Generic NameENDOSCOPIC CLIP APPLIER
Baseline Catalogue Number530
Baseline Device FamilyENDOSCOPIC CLIP APPLIER
Baseline Device 510(K) NumberK924929
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed07/01/1993
Manufacturer (Section F)
CONMED CORPORATION
310 broad street
utica NY 13501
Manufacturer (Section D)
CONMED CORPORATION
310 broad street
utica NY 13501
Manufacturer Contact
nancy crisino
525 french road
utica , NY 13502
(315) 624 -3078
Device Event Key364967
MDR Report Key375876
Event Key354685
Report Number1317214-2002-00003
Device Sequence Number1
Product CodeHBT
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/09/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/09/2002
Was Device Evaluated By Manufacturer? Yes
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 January 30, 2009

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