MAUDE Adverse Event Report: ETHICON INC. LAPRA TY CLIP; CLIP, IMPLANTABLE

Catalog Number MIC4034

Device Problems Positioning Failure (1158); Material Integrity Problem (2978)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cholecystectomy procedure in 2022 and clips sutures were used.During the procedure, the clips could not be taken from the cartridge using the applier.It was reported that the clips were picked manually and did not properly close.No adverse patient consequences were reported.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Is not available for the initial report, a follow-up report will be filed as appropriate.Device analysis: twelve sterile reloads were returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that twelve mic4034 reloads were received with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device for its functionality.Upon functional testing of the clips, the instrument loaded, retained, and deployed clips as intended.The clips were as intended and conform to our manufacturing requirements.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clips performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Ten sterile reloads were returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that ten mic4034 reloads were received with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device for its functionality.Upon functional testing of the clips, the instrument loaded, retained, and deployed clips as intended.The clips were as intended and conform to our manufacturing requirements.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clips were performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Eighteen sterile reloads were returned for evaluation.Visual inspection and functional testing were conducted on the returned device.According to our analysis process, thirteen samples were taken randomly to be analyzed.Visual analysis of the returned samples revealed that thirteen mic4034 reloads were received with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device for its functionality.Upon functional testing of the clips, the instrument loaded, retained, and deployed clips as intended.The clips were as intended and conform to our manufacturing requirements.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clips performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Events reported via: 2210968-2022-02260, 2210968-2022-02261, 2210968-2022-02262, 2210968-2022-02263, 2210968-2022-02259, 2210968-2022-02264, 2210968-2022-02265, 2210968-2022-02266, 2210968-2022-02267, 2210968-2022-02268, 2210968-2022-02270,2210968-2022-02271, 2210968-2022-02272, and 2210968-2022-02273.

• Brand Name: LAPRA TY CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert- koch strass1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13951269
• MDR Text Key: 288209166
• Report Number: 2210968-2022-02269
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MIC4034
• Device Lot Number: RPBCQDQ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• 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