MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	8360-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The adverse event is filed under aic reference: (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (part#: 8360-10) was used during a laparoscopic cholecystectomy on (b)(6) 2025.According to the complainant the double action grasper was stuck open in the patient.Once removed from the patient grasper tips broke off on the back table.Reportedly there was a 10 minute delay to the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
The adverse event is filed under aic reference(b)(4).Additional information: d4 device information updated d9 device returned to manufacturer.The sample was received in a box with bubble wrap.The body of the product has both jaws detached.Sample was received with jaws in a separate sealed plastic container within the returned package.The spacer is still assembled within the sample body.The links are still attached to the body of the instrument.The body of the product has both jaws detached.Sample was received with jaws in a separate sealed plastic container within the returned package.The spacer is still assembled within the sample body.The links are still attached to the body of the instrument.No shearing or evidence of breaking.Everything is intact, by appearance, therefore disassembly is confirmed.This product may have been reserviced due to the following evidence: the 8360-10801 insulation is not an oem part, but a replacement part, as identified by the thickness of the part, and the surface finish is smoother and glossier.The flushport valve is missing.Defect was confirmed.An approved project was initiated to address the issue of this nature.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22523211
• Report Number: 2916714-2025-00056
• Device Sequence Number: 15456686
• Product Code: NBH
• UDI-Device Identifier: 00885554016161
• UDI-Public: (01)00885554016161(10)50437690
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: 50437690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown