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

Model Number 174317

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photo(s) noted that the plastic sheath along the shaft had shearing damage and was peeling.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur where an excessive force or leverage is applied to the device while retracting the clevis assembly and the clevis boot is subsequently damaged.This subsequent damage may result in improper retraction and deployment of the jaws during articulation and may cause shearing of the plastic sheath.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic cholecystectomy, the surgeon put the instrument down the port and noticed the insulation torn on the distal end of the shaft of the instrument.Another instrument was pulled and used 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
• 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: 9835984
• MDR Text Key: 183538830
• Report Number: 2647580-2020-00966
• Device Sequence Number: 1
• Product Code: HDA
• UDI-Device Identifier: 10884523000832
• UDI-Public: 10884523000832
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P9E1274Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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