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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ROTO-LOK HUNTER BOWEL/LL 37CM GRASPING FORCEPS

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INTEGRA YORK, PA INC. ROTO-LOK HUNTER BOWEL/LL 37CM GRASPING FORCEPS Back to Search Results
Catalog Number 625164LL
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2018
Event Type  Malfunction  
Manufacturer Narrative

The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

 
Event Description

A company representative reported on behalf of physician that on (b)(6) 2018, the 625164ll roto-lok hunter bowel jaws was not working properly during laparoscopic cholecystectomy procedure. Upon pulling the instrument out of the port, it was noted that the hinge pin that holds the jaws of the instrument was missing. Unable to locate the missing piece in the patient and too dangerous to keep looking in the patient¿s abdomen. The pin was not retrieved in the patient. No patient injury or death alleged. There is no information provided regarding product delay in surgery. Additional information has been requested but no other clinical information has been provided.

 
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Brand NameROTO-LOK HUNTER BOWEL/LL 37CM
Type of DeviceGRASPING FORCEPS
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
Manufacturer (Section G)
INTEGRA YORK, PA INC.
589 davies drive
york PA 17402
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7459849
MDR Text Key107087762
Report Number2523190-2018-00060
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK931928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number625164LL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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