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

Model Number 600-290

Device Problems Break (1069); Crack (1135); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Valleylab force fx esu unit was being used with an integra jarit active cord (p/n 600-290).When the esu unit was activated by surgeon, the active cord "popped" and broke into 2 pieces at the accessory attachment point.The reusable cord may have had microscopic cracks that were not visible in the sheath.Frays in the cord may have contributed to unequal electrical current and the "popping" of the cord and accessory attachment.The sequestered esu bovie unit - was checked out by biomed and no malfunction noted.

• Brand Name: JARIT
• Type of Device: COAGULATOR- CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 589 davies drive; york PA 17402
• MDR Report Key: 4755153
• MDR Text Key: 5828201
• Report Number: 4755153
• Device Sequence Number: 1
• Product Code: KNF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 600-290
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR