MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG DEBAKEY RING HANDLE BULLDOG CLAMP; VASCULAR CLAMP

Model Number	320185
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for inspection and was evaluated on the basis of photographs.One of the jaw blades is bent away from the other, making it impossible for the instrument to perform its clamping function and conceivably due to rough handling.Review of the device history record revealed no issues during manufacturing and confirmed device conformance to specifications at time of release.
Event or Problem Description
During vascular surgery for dialysis access, the debakey ring handle bulldog clamp would not close properly to stop blood flow and the artery kept bleeding out.It was reported that no patient death occurred.Repeated attempts have been made to obtain additional information on patient outcome, but none has been forthcoming.

• Brand Name: DEBAKEY RING HANDLE BULLDOG CLAMP
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 13590223
• Report Number: 8010168-2022-00001
• Device Sequence Number: 4973911
• Product Code: DXC
• UDI-Device Identifier: 10381780134367
• UDI-Public: (01)10381780134367(10)AA2004
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: 320185
• Device Catalogue Number: 320-185 / LK 217-12-01
• Device Lot Number: AA2004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown