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

Model Number 174317

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 10/02/2019

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 a laparoscopic cholecystectomy, the end of the grasper snapped off upon entering the abdomen.In addition, the missing bit was retrieved in the patient's abdomen.

• 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: 9253869
• MDR Text Key: 164253094
• Report Number: 2647580-2019-05414
• Device Sequence Number: 1
• Product Code: HDA
• UDI-Device Identifier: 20884523000839
• UDI-Public: 20884523000839
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P9A0725Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• Date Device Manufactured: 01/03/2019
• 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