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

Model Number 134031

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 02/14/2020

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 breast surgery, the devices fired but the clips were distorted and twisted.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.The first instrument was received partially applied with one remaining clip.Visual inspection of the instrument revealed no abnormalities.Functionally, the instrument was fired once in air and proper clip formation was confirmed.The jaw and handle moved smoothly through the firing cycle and returned to the open position.When the cartridge was empty, the interlock engaged and prevented the jaw from approximating.The second and third instruments were received fully applied.Visual inspection of the instruments revealed no abnormalities.Functionally, the empty cartridges precludes firing evaluations; however, the interlocks were engaged and properly prevented the jaw from approximating.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 breast surgery, the devices fired but the clips were distorted and twisted.The clips that misfired fell into the cavity of the patient and were retrieved by the surgeon using forceps.Surgical time was extended probably 15 minutes.Further clip applicators were opened until one was found that worked, to allow safe sealing of vessels and completion of the case.There was no patient injury.

• 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: 9780802
• MDR Text Key: 181788391
• Report Number: 2647580-2020-00830
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20884521057521
• UDI-Public: 20884521057521
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K853650
• 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,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134031
• Device Catalogue Number: 134031
• Device Lot Number: P9G1171Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2019
• 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