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

Model Number 176630

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic bilateral varicocelectomy procedure, when the doctor fired the device on spermatic vein the device jaws blocked and could not be open.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of four photos and one device.A visual inspection of the returned photos noted: the first photo depicts two appliers, one with the jaws open, and the other what appears to be tissue in the jaws.The second photo depicts a different angle of the first photo.The third photo depicts the jaws of the applier with what appears to be a clip with tissue between the closed jaws.The fourth photo depicts a close-up of the third photo.Visual inspection of the instrument revealed that the jaws were clamped with two fully formed clips lodged between the jaws.The handle was observed to be in a partially actuated position.Functional evaluation noted that the handle actuation could not be completed due to the presence of the lodged clips.Upon removal of the lodged clips, the instrument was observed to function properly.Twelve clips advanced into the jaws, formed properly, and were held securely in place after full formation was achieved and the firing handle was released.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if an attempt is made to apply a clip over a fully formed clip or obstruction.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9729061
• MDR Text Key: 180316657
• Report Number: 9612501-2020-00307
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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: 02/28/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9C1475Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 55