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

Model Number 134044

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the handle did not move well after clipping, and the loading was slow.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with five 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.

• Brand Name: PREMIUM SURGICLIP
• 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: 9743021
• MDR Text Key: 180514360
• Report Number: 2647580-2020-00672
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057531
• UDI-Public: 10884521057531
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K853650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 134044
• Device Catalogue Number: 134044
• Device Lot Number: P8C1529CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• 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