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

Model Number	176657
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681); Biliary Leak (4820)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, while being used on a bile duct injury described as a bile duct nick occurred with associated tissue damage.The cystic artery and duct were dissected out.The surgeon planned to clip and divide the cystic artery in preparation for cholangiography.The first attempted clipping of the cystic artery resulted in scissoring of the clip.Surgeon did not see obvious deformity of clip applier and tried to apply a second clip.Which resulted in even worse scissoring of clip which did not occlude and resulted in arterial bleeding as well as immediate draining of bile just below the artery.Third clip was loaded with no issue, but clip fell out of the jaws.It was identified that there was a full thickness tear less than 1mm in size of the common hepatic duct approximately 1cm above the cystic duct junction.Another clip applier was used to continue.Intraoperative consultation by trained hepato-pancreato-biliary (hpb) surgeon talked to colleague in portland and it was recommended leaving a drain in place and transferring patient for an endoscopic retrograde cholangiopancreatography (ercp).A secondary procedure with stent placement was performed to treat the bile duct injury.They were able to perform cholangiography <(>&<)> showed stones.Completed cholecystectomy and left drain in upper right quadrant.

• Brand Name: ENDO CLIP II
• Common Device Name: 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25541186
• Report Number: 9612501-2026-01654
• Device Sequence Number: 9633771
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: (01)10884521057869(17)301231(10)J6A4230NY
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J6A4230NY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 01/31/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown