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

Model Number 176630

Device Problem Fail-Safe Problem (2936)

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

Event Date 04/07/2021

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 driver was broken.Functionally, the instrument was applied to the test media.The instrument cycled without binding.The clip advanced into the jaws but jaws did not close to form the clip.The function of the driver is to advance through the jaw channel and make them close.When the driver moves backwards, jaw will open.When the driver is broken, the clips will not load properly into the jaws as expected.It was reported that the safety interlock deployed prior to all staples or clips firing.The reported issue was confirmed.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.However, a component failure was identified during product analysis.A process improvement has been initiated to address this issue.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the surgeon was not able to squeeze the handle and there was issue experienced with the loading or firing of the clips.Another product was opened to complete the case.There was no patient injury.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12166873
• MDR Text Key: 261508829
• Report Number: 9612501-2021-01164
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 07/14/2021

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: 07/31/2023
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J0H2605Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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