MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO CLINCH II; FORCEPS, OBSTETRICAL

Model Number 174317

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while being applied on dissection during a laparoscopic sleeve gastrectomy, the devices did not grasp properly, and the jaws were broken.They used another device to complete the case.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while being applied on dissection during a laparoscopic sleeve gastrectomy, the device did not grasp properly, and the jaws were broken.They used another device to complete the case.There was no patient injury.

• Brand Name: ENDO CLINCH II
• Type of Device: FORCEPS, OBSTETRICAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8212362
• MDR Text Key: 131917809
• Report Number: 2647580-2019-00038
• Device Sequence Number: 1
• Product Code: HDA
• UDI-Device Identifier: 20884523000839
• UDI-Public: 20884523000839
• Combination Product (y/n): N
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P7M1479PX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1