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

Model Number 8886848813

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); No Device Output (1435); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic robot-assisted distal gastrectomy procedure, while clipping the splenic artery, the handle was squeezed firmly, but it did not feel like it was being squeezed, and the clip did not close firmly until the end either.The clip was in a half-open state, so attempts were made to release it from the tissue.However, the clip was stuck in the tissue and could not be released smoothly.While performing the release operation several times, the entire clip slipped into the abdominal cavity.All parts were removed from the abdominal cavity with the grip of laparoscopy.When the collected defective product was checked, it was found that the clip was closed but still in the loaded state.To check whether the applier could move after the surgery, the remaining clip was loaded and fired, but clipping could be performed without any problem.A competitor device was used to resolve the issue.

Manufacturer Narrative

D10.Concomitant product: 8886848813, 8886848813 laproclip 2x12 x10 (lot#n3a0159y).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.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the clip was fully formed but not completely deployed from the cartridge.The clinical instrument was not received.No other visual abnormalities were observed.Functionally, a representative instrument was used for testing.The cartridge was loaded into the representative instrument and fired, the pusher advanced properly and deployed the clip.It was reported that the instrument locked on tissue.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.It was also reported that the was a poor clip formation, the component disengaged, clip slippage, and no tactile feedback.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each d evice are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to fully squeeze the handle may result in mis-formed clips which may result in incomplete closure and lack of hemostasis.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The two devices were available for evaluation.Visual insp ection noted that the clip was fully formed but not completely deployed from the cartridge.The clinical instrument was not received.No other visual abnormalities were observed.Functional testing found a representative instrument was used for testing.The cartridge was loaded into the representative instrument and fired, the pusher advanced properly and deployed the clip.It was reported that the instrument locked on tissue.The reported issue was confirmed.The most likely cause could not be established from the information available.Replication of the clip not fully deployed condition may occur if the trigger of the instrument was not fully actuated releasing the clip from the cartridge.It was also reported that there was poor clip formation, the component disengaged, clip slippage, and there was no tactile feedback.The reported issues were not confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to fully squeeze the handle may result in malformed clips which may result in incomplete closure and lack of hemostasis.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: 18963559
• MDR Text Key: 338761885
• Report Number: 1219930-2024-01289
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: N3A0159Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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: SEE H11