MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CLAW FORCEP, SPRING LOADED, INSULATED SHAFT 5MM 33CM JARIT INSTRUMENT; ACCESSORIES, GYNECOLOGIC

Model Number 600-137

Device Problems Material Separation (1562); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

Event Description

Jarit 600-137 claw forcep, spring loaded, insulated shaft, 5mm 33cm, handle separated during pelviscopy procedure.It was noted that the pivot pin had fallen out of the handle and was accounted for, and the device was removed from the surgical field.Fda safety report id# (b)(4).

• Brand Name: CLAW FORCEP, SPRING LOADED, INSULATED SHAFT 5MM 33CM JARIT INSTRUMENT
• Type of Device: ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 8535916
• MDR Text Key: 142739481
• Report Number: MW5086022
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600-137
• Device Catalogue Number: 600-137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR