MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; COOLEY MULTI-PURPOSE CURVED CLAMP

Model Number	CH6622
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris requested the cooley multi-purpose curved clamp subject of the reported event back for evaluation.The investigation of the event is currently in progress.A follow-up report will be submitted if additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their cooley multi-purpose curved clamp was "attributing to localized bleeding".
Additional Manufacturer Narrative
The cooley multi-purpose curved clamp subject of the reported event was not returned for evaluation.Without the return and evaluation of the device the cause of the event could not be determined.The device history record was reviewed and confirmed no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.
Additional Manufacturer Narrative
The follow-up mdr was submitted in error as the cooley multi-purpose curved clamp was received back for evaluation.The cooley multi-purpose curved clamp was evaluated and found no issues with the function or operation; the reported event could not be duplicated.The device history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: COOLEY MULTI-PURPOSE CURVED CLAMP
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23311341
• Report Number: 1527821-2025-00025
• Device Sequence Number: 5826825
• Product Code: DXC
• UDI-Device Identifier: 10885403031939
• UDI-Public: (01)10885403031939(10)A21XHE
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CH6622
• Device Catalogue Number: CH6622
• Device Lot Number: (10)A21XHE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown