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

Model Number 176630

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

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 that the trip lever was out of position, the instrument¿s trigger was received partially applied, and the clip counter was no longer active.No visual abnormalities were observed with the instrument.Functional testing found that the instrument was cycled but the clip did not load and the pusher bar was not loading a clip.The handle was manually put in its home position to fire the instrument and during the first fire the clip did not came out.The pusher bar did not advance to pick up the clips but the ratchet system worked appropriately.In addition, the device received was dismantled in order to inspect inner components and it was observed that the pistol was properly assembled.There was also a slight difference on the position of the trip lever against the spring.It was reported that the parts or components of the device in the packaging were missing.The reported issue was confirmed.The most likely root cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, pre-operatively, the device was opened and it revealed that there were no clips within the device.There was no patient involvement.

• 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 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10397598
• MDR Text Key: 202619093
• Report Number: 9612501-2020-01142
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9F2192Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2019
• 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