MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA JARIT; COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 600318

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

The surgeon was using the reusable l hook inside the patient during a laparoscopic procedure.As he was using the l hook, the tip broke off into the patient.The tip was able to be recovered and was removed from the patient.

• Brand Name: INTEGRA JARIT
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 16983417
• MDR Text Key: 315759957
• Report Number: 16983417
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600318
• Device Catalogue Number: 600-318
• Device Lot Number: AB2107
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female