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Adverse Event Report

COOPERSURGICAL COOPER SURGICAL (MARLOW) CONE-NOSE DOLPHIN GRASPER   back to search results
Model Number N683
Event Description

During preperitoneal laparoscopic bilateral inguinal herniorrhaphy with mesh, a grasper malfunctioned. Upon initial inspection of the instrument the surgeon & staff thought all pieces were intact. After the procedure was completed and the instrument was decontaminated with closer inspection it was suspected that a small piece of the hinge mechanism was missing. An xray was taken in phase 2 recovery showing a small metal foreign body. The pt elected to not have further surgery on 4/9 after discussion w/surgeon.

 
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Brand NameCOOPER SURGICAL (MARLOW)
Type of DeviceCONE-NOSE DOLPHIN GRASPER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
COOPERSURGICAL
15 forest parkway
shelton CT 06484
Device Event Key159337
MDR Report Key163694
Event Key153818
Report NumberMW1013564
Device Sequence Number1
Product CodeGCJ
Report Source Voluntary
Report Date 04/13/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberN683
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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