MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP III; CLIP, IMPLANTABLE

Model Number 176630

Device Problems Component Missing (2306); Mechanics Altered (2984)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the trip lever was out of position.Functionally, the clip applier was cycled but the clip did not load.The pusher bar was observed to not be functioning properly.A review of the device history record for the clip applier indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.The trip lever out of position preventing the clips from loading properly.A process improvement has been initiated to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, preoperative to laparoscopic surgery, the device was checked and there was no clip - it was empty.Another device was used to resolve the issue in order to complete the case.There was no patient involvement.Medtronic's initial evaluation of the incident device found trigger was partially applied.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11601817
• MDR Text Key: 243340979
• Report Number: 9612501-2021-00521
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2021

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: 09/30/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9K1933Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• 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