MAUDE Adverse Event Report: AESCULAP AG AESCULAP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PO958R
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported to aesculap inc.That a monopolar handle without ratchet (part # po958r) was used during a colectomy, sigmoid, laparoscopic procedure on (b)(6) 2025.According to the complaint description, multiple inserts were stiff and difficult to open/manipulate.The type of procedure was a laparoscopic sigmoid colectomy.There was a 20-minute delay while converting to an open laparotomy procedure.2916714-2025-00043, aic reference (b)(4), 2916714-2025-00044, aic reference (b)(4), 2916714-2025-00045, aic reference (b)(4), 2916714-2025-00046, aic reference (b)(4), 2916714-2025-00047, aic reference (b)(4), 2916714-2025-00048, aic reference (b)(4), 2916714-2025-00049, aic reference (b)(4), aic reference (b)(4).
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: d4 device information updated; d9 device returned to manufacturer; f9 approximate age of device.Investigation results: the product is in used condition and the instrument shows no visible deviations.The device was functionally tested with the result that the device is within the given specifications.The reported damage of the product could not be confirmed.No deviation from the specifications could be found.

• Brand Name: AESCULAP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 22344815
• Report Number: 2916714-2025-00050
• Device Sequence Number: 8512439
• Product Code: GEI
• UDI-Device Identifier: 04038653464081
• UDI-Public: (01)04038653464081(11)231001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/05/2025
• Report Date (Section F): 06/27/2025

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: PO958R
• Device Catalogue Number: PO958R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2025
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 06/27/2025