MAUDE Adverse Event Report: Aesculap Inc. N/A; ACCESSORIES,ARTHROSCOPIC

Model Number	8360-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 hysterectomy procedure sometime in (b)(6) 2026.The device broke apart during a bilateral hysterectomy, and an x-ray was taken to ensure that no fragment remained in the surgical field.Additional information has been requested but not yet provided.
Additional Manufacturer Narrative
This report 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.

• Brand Name: N/A
• 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: elena reifenstein ; 3773 corporate parkway; center valley, PA 18034 ; +1(833)425-1464
• MDR Report Key: 50737754
• Report Number: 2916714-2026-00027
• Device Sequence Number: 21491135
• Product Code: NBH
• UDI-Device Identifier: 00885554016161
• UDI-Public: (01)00885554016161
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 8360-10
• Device Catalogue Number: 8360-10
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/11/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female