MAUDE Adverse Event Report: AESCULAP INC. KELLY FORCEPS DEL CVD 140MM; HEMOSTAT

Model Number	BH135R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with a hemostat via information received from medsun (b)(4).According to the complaint description, during the creation of a left brachial artery to left axillary vein arteriovenous graft performed in (b)(6) 2025, the tip of the crile hemostatic forceps broke while the surgical technician was unclamping off the surgical site.An x-ray was performed and the results confirmed that there were no fragments in situ.The adverse event is filed under aesculap reference no.(b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: KELLY FORCEPS DEL CVD 140MM
• Common Device Name: HEMOSTAT
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 21634893
• Report Number: 2916714-2025-00010
• Device Sequence Number: 15328175
• Product Code: HRQ
• UDI-Device Identifier: 04038653025756
• UDI-Public: (01)04038653025756(11)200831(10)4511842926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025
• Report Date (Section F): 03/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BH135R
• Device Catalogue Number: BH135R
• Device Lot Number: 4511842926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 03/18/2025