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

Model Number 8886848813

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

According to the reporter, during an abdominal procedure, when the clip appliers were pulled back, the clips did not come loose.The clip and clip applier were still connected.In the end, it was possible to release the clip, but it was difficult.The operating time was simply extended.Another clip applier was used to resolve the issue.

Manufacturer Narrative

D10 concomitant products: 8886848812, 8886848812 laproclip 6x12 x6 (lot#:n3d0267y) 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.

Manufacturer Narrative

D10 concomitant product: 8886848813, 8886848813 laproclip 2x12 x10 (lot#n0j0904y); 8886848813, 8886848813 laproclip 2x12 x10 (lot#n0k0253y) additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Twenty two devices were available for evaluation.The eval uation found no potentially contributing factors, and the sample met all related specifications.It was reported that the device was difficult to unload.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18598807
• MDR Text Key: 334064068
• Report Number: 1219930-2024-00458
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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 Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N1J0734Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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
• Treatment: PLEASE SEE NOTE ON H11; SEE H10