MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 8886848813

Device Problems Break (1069); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

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 the closure of the gallbladder artery in a laparoscopic cholecystectomy procedure, after one clip was closed, the inner clip did not separate from the outer clip.Both were taken out together.It was also stated that another clip was damaged and could not be used.A new device was used to complete the procedure.There was no patient injury.

Manufacturer Narrative

Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the first cartridge noted that the clip was fully formed but not completely deployed from the cartridge.The visual inspection of the second cartridge noted it was received fully applied, the clip body was broken in half, and was missing the other half.The tracks were received.The clinical instrument was not received.No other visual abnormalities were observed.Functional evaluation could not be performed on the damaged clip.Since the clinical instrument was not received the loading unit was loaded into a pmv representative instrument and fired; the pusher advanced properly and deployed the clip.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.Replication of the clip body fracture may occur if the clip is applied over indicated tissue or an obstruction that exceeds the clip capacity.Replication of the clip not fully deployed condition may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.The root cause of the observed damage was due to the product not being used as indicated 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.

• Brand Name: LAPRO-CLIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9453291
• MDR Text Key: 170466062
• Report Number: 1219930-2019-06867
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• Combination Product (y/n): N
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N9A0484Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 78