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

Model Number 176625

Device Problem Device Slipped (1584)

Patient Problems Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)

Event Date 04/26/2022

Event Type  Injury  

Event Description

According to the reporter, post-operatively, there was a bile leakage.It was noted that there was no problem encountered during the procedure.The clips from the 2 devices did not hold the tissue.To resolve the issue, the surgeon control with endoscopic retrograde cholangiopancreatography procedure that was performed the next day to resolve the issue.

Manufacturer Narrative

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

• Brand Name: ENDO CLIP
• 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: 14380136
• MDR Text Key: 291609095
• Report Number: 9612501-2022-00796
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J0G0764NY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 07/06/2020
• 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
• Patient Outcome(s): Required Intervention