MAUDE Adverse Event Report: AESCULAP AG MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.; REUSABLE INSTRUMENTS

Model Number	PM408R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant during a laparoscopic procedure, the jaw broke inside the patient.Piece retrieval was completed successfully and x-ray results confirmed this also.Additional information was not provided but has been requested.
Additional Manufacturer Narrative
The adverse event is filed under aic reference xc (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation results: the product was not returned to the manufacturer for investigation.The investigation was based upon historical data analysis, pictures and event description.On the basis of the provided picture it can be observed that one of the pinned movable jaws is loose.Batch history review: the batches could be determined on the basis of the date of manufacture, in the december 2024 period (52960208, 52961039, 52962492, 52963423, 52964032, 52965039, 52965895).For all batches: the device history records have been checked for all leading device(s) lot numbers and the products found to be according to specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion/ preventive measures: based on the current information, a clear root cause conclusion cannot be drawn.The reported damage of the product could be confirmed.There is no indication for a design-, manufacturing- and/or material-related failure.In the event that the complaint sample will be provided for investigation in the future, an update of this report will be provided unsolicited.

• Brand Name: MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 23536101
• Report Number: 2916714-2025-00074
• Device Sequence Number: 10026818
• Product Code: HGI
• UDI-Device Identifier: 04038653322855
• UDI-Public: (01)04038653322855
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026
• Report Date (Section F): 11/12/2025

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: PM408R
• Device Catalogue Number: PM408R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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: Unknown
• Date Report Sent to FDA: 11/12/2025