MAUDE Adverse Event Report: INTEGRA YORK PA, INC. JARIT; COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 600-318

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 05/12/2017

Event Type  malfunction  

Event Description

Small insulation defect at tip of left l hook caused an arc of electricity away from the site intended to be cauterized during a laparoscopic cholecystectomy procedure.Manufacturer response for jarit l hook cautery probe, jarit l-hook electrocautery probe (per site reporter): aware of problem and has replaced all l-hooks.

• Brand Name: JARIT
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies dr.; york PA 17402
• MDR Report Key: 6629773
• MDR Text Key: 77218549
• Report Number: 6629773
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 600-318
• Device Catalogue Number: 600-318
• Other Device ID Number: 1363487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1