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

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.

Manufacturer Narrative

The device was returned for evaluation.A visual inspection of the instrument showing wear, and a broken pin, it is noticed that the pin is missing where the jaw is located.The complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: ROTO-LOK HUNTER BOWEL/LL 37CM
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7459849
• MDR Text Key: 107087762
• Report Number: 2523190-2018-00060
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K931928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 625164LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1