MAUDE Adverse Event Report: INTEGRA SURGICAL (JARIT) LAPAROSCOPIC TENACULUM; TENACULUM FORCEPS

Model Number 605-152

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2018

Event Type  malfunction  

Event Description

During procedure, the laparoscopic tenaculum broke.When removed, it was noted that a small screw was missing.X-ray was read as positive for foreign body.

• Brand Name: LAPAROSCOPIC TENACULUM
• Type of Device: TENACULUM FORCEPS
• Manufacturer (Section D): INTEGRA SURGICAL (JARIT); 589 davies drive; york PA 17402
• MDR Report Key: 7693351
• MDR Text Key: 114295975
• Report Number: MW5078423
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• 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: 07/09/2018

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: 605-152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2018
• 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: 44 YR