MAUDE Adverse Event Report: INTEGRA/JARIT INSTRUMENTS LAPAROSCOPIC TENACULUM; TENACULUM FORCEP

Model Number 605-152

Device Problem Material Fragmentation (1261)

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

Event Date 05/19/2016

Event Type  Injury  

Event Description

During operative case, laparoscopic tenaculum broke within patient.No broken pieces found within abdominal cavity.X-ray was negative for pieces.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number below.

• Brand Name: LAPAROSCOPIC TENACULUM
• Type of Device: TENACULUM FORCEP
• Manufacturer (Section D): INTEGRA/JARIT INSTRUMENTS; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 6113860
• MDR Text Key: 60542633
• Report Number: MW5066180
• Device Sequence Number: 1
• Product Code: GEN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 605-152
• Device Lot Number: 1240040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR