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

Model Number 8886848813

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

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 laparoscopic cholecystectomy, on a gallbladder arterial occlusion, the clips did not provide good clamping force.They clipped above the gallbladder artery and there was a feeling of loosening.The clip cartridge was able to be properly loaded onto the handle.They replaced another clip to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photo of two devices.The received photo depicts two cartridges in a plastic bag.The clips are fully formed, but not completely deployed from the cartridges.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related conditions.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 misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photo and two devices.The visual inspection of the returned photo depicts two cartridges in a plastic bag.The clips are fully formed but not completely deployed from the cartridges.Indicating the instrument may not have been cycled completely.Visual examination of the cartridges noted that the clips were fully formed but not completely deployed from the cartridges.Since the clinical instrument was not received the loading units were loaded into a pmv representative instrument and fired; the pushers advanced properly and deployed the clips.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 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 misuse of the product 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
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 80301 ; 2034925563
• MDR Report Key: 7522632
• MDR Text Key: 108549386
• Report Number: 1219930-2018-02704
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521057668
• UDI-Public: 20884521057668
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2018

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: 10/31/2022
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N7K0105X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 08/31/2018
• Supplement Dates FDA Received: 08/23/2018; 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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