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

Model Number 8886848882

Device Problems Mechanical Problem (1384); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2020

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 laparoscopic cholecystectomy, when the surgeon was trying to clip bile duct, the clip was able to form correctly.The outer layer did not lock the notch of the inner layer while clipping.They opened a new one to complete the case.There was no patient injury.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, when the surgeon was trying to clip the bile duct, the clip was unable to form correctly.The clip outer layer did not come lock after the inner layer, the incompletely closed caused the clip to be slipped away from the vessel.The reload was replaced to resolve the issue.There was no patient injury.

Manufacturer Narrative

Additional information: b5, d10, g4, h3, h6 h3.Evaluation summary: post market vigilance (pmv) led an evaluation of one photo and one device.A visual inspection of the returned photo noted: the photo depicts a clip body with the track not properly seated within the body.The visual inspection of the device noted only the clip body was received with the tracks not inserted properly at the distal end of the clip.The cartridge was not returned for evaluation.Functionally; since the cartridge was not returned for evaluation, an evaluation could not be performed.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 observed condition may occur if the clip was not properly applied and mishandled during the clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 9927715
• MDR Text Key: 186531223
• Report Number: 1219930-2020-01565
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057678
• UDI-Public: 10884521057678
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

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: 04/30/2023
• Device Model Number: 8886848882
• Device Catalogue Number: 8886848882
• Device Lot Number: N8D0331X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR