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

Model Number 8886848882

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

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic transverse colectomy, at the third firing, after the reported product was fired on the middle colic vein, the clip could not be released.The physician attempted to remove the device by re-squeezing the handle and pulling the device with a slightly force, etc., but was unable to release the device, so he transferred to laparotomy.After that, he released each black part which stored the clip from the applier and pulled it with a slightly force, the device was first released from the storage part of the clip.However, because bleeding occurred, the physician used his hands to stop bleeding so he could not collect the clip itself.After that, the 12mm clip was collected from the patient¿s cavity, but actually it was the 8mm clip which could not be released.Regarding the storage parts of the clip, it was unknown which one was the reported product so all of them were collected.The fixing pin was not disengaged from the jaws was low, because the physician squeezed the handle several times.And among the collected clip storage parts, it was found that when the 8mm clip was pushed out, the transparent pusher which stopped at a quite front position.The part fell into the patient's cavity and could not be retrieved.The surgical time was extended by more than 30 minutes.Additional tissue resection was required due to the issue.There was tissue damage.The device was removed from the tissue by force and tissue damage was caused.

Manufacturer Narrative

Issue with clips releasing from cartridge should no longer be used.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: 7910145
• MDR Text Key: 121745088
• Report Number: 1219930-2018-05217
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521057675
• UDI-Public: 20884521057675
• Combination Product (y/n): N
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8886848882
• Device Catalogue Number: 8886848882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention