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

Model Number 8886848813

Device Problems Failure to Fire (2610); Detachment of Device or Device Component (2907); Firing Problem (4011)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/09/2018

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 lap.Colectomy of cecum with terminal ileum, when the surgeon squeezed the handle to fire, the cartridge disengaged from the shaft and the clip was not released from the jaws.The surgeon fired a metal clip to the central side of the vessel.The procedure was completed with another device.The surgical time was extended by less than 30 min.The part fell into the patient's cavity and was retrieved.The device was removed from the tissue by additionally resecting the tissue.There was no patient harm.

Manufacturer Narrative

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 device.Visual examination of the cartridge noted that the clip was fully formed but not completely deployed from the cartridge.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.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.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: 7722937
• MDR Text Key: 115273845
• Report Number: 1219930-2018-04109
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

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: 04/30/2023
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N8D0151X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/02/2018
• Supplement Dates FDA Received: 10/05/2018; 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1