MAUDE Adverse Event Report: AESCULAP AG SOVEREIGN ATR.GRASP.FCPS D:5/360MM W/RAT; REUSABLE INSTRUMENTS

Model Number	PL232R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 sovereign atr.Grasp.Fcps d:5/360mm w/rat.(part# pl232r) was used during a robotic hysterectomy and sacral colpopexy procedure.According to the complainant the jaw of the instrument broke during the procedure.There were no pieces that detached or were retrieved; an x-ray was taken and results confirmed that no fragments remained in situ.Additional information was not provided.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Correction: d4 udi number.Additional information: d4 lot number.D9 device returned to manufacturer.F9 approximate age of device.One (1) sample provided was returned to the manufacturing site for technical evaluation.Results of the investigation determined visually that there was a fracture in the hinge area.The broken adapter part is severely damaged and has material build-up or friction points.This indicates an overload situation.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.There are no similar complaints against the reported lot number with this error pattern.Based on the investigation findings, the cause of the damage was unable to be determined.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: SOVEREIGN ATR.GRASP.FCPS D:5/360MM W/RAT
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20189776
• Report Number: 2916714-2024-00133
• Device Sequence Number: 12796633
• Product Code: HTD
• UDI-Device Identifier: 04046964074851
• UDI-Public: (01)04046964074851(11)210702(10)52696293
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024
• Report Date (Section F): 09/11/2024

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: PL232R
• Device Catalogue Number: PL232R
• Device Lot Number: 52696293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/21/2024
• 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 Sex: Female
• Date Report Sent to FDA: 09/11/2024