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

Model Number 174317

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy, the device grasp properly however the handles bind while being applied during tissue mobilization.The nail between the endoclinch jaws fell in the patient and the operation was converted from lap chole to open surgery in order to take the nail out.

• 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
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7438631
• MDR Text Key: 105756631
• Report Number: 2647580-2018-01879
• Device Sequence Number: 1
• Product Code: HDA
• UDI-Device Identifier: 10884523000832
• UDI-Public: 10884523000832
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Device Lot Number: 174317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1