MAUDE Adverse Event Report: TELEFLEX INCORPORATED MINILAP; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Catalog Number PGAC300

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2022

Event Type  malfunction  

Event Description

We were performing a laparoscopic salpingectomy, using the teleflex medical mini lap minigrip alligator grasper, when one of the ratchets (that is used to open and close the jaw) fell off while clamped onto the fallopian tube.We were able to reopen the jaws (and finish the surgery) because there is another ratchet on the other side.This could have been very bad if we would not have been able to open the jaws.

• Brand Name: MINILAP
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15319484
• MDR Text Key: 298887383
• Report Number: 15319484
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PGAC300
• Device Lot Number: GML-00335
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1