MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP III; CLIP, IMPLANTABLE

Model Number 133650

Device Problems Mechanical Problem (1384); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

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 head and neck procedure, on ligation of the tissue or vessel, the surgeon was able to squeeze the handle, the clips were fired and were malformed.The clips did close all the way and crisscrossed.A new clip applier was opened to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with four remaining clips.Visual inspection of the instrument revealed no abnormalities.Functionally, the instrument was fired once in air and proper clip formation was confirmed.The remaining clips were then fired on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and returned to the open position and each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaw from approximating.Note that the information for use brochure which accompanies each product shipment cautions the user as follows: ensure that the handles are squeezed together firmly as far as they will go.Failure to squeeze the handles completely can result in clip malformation and possible bleeding or leakage.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a head and neck procedure, on ligation of the tissue or vessel, the surgeon was able to squeeze the handle, the clips were fired and were malformed.The clips did not close all the way and crisscrossed.A new clip applier was opened to complete the case.There was no patient injury.

• Brand Name: PREMIUM SURGICLIP III
• Type of Device: CLIP, IMPLANTABLE
• 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: 9504253
• MDR Text Key: 172410266
• Report Number: 2647580-2019-06266
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: 10884521517394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P9J0784Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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