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

Model Number	US354
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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
According to the complainant: "the us354 monopolar cord was plugged into the power source in the operating room.The operating room team hurt a 'pop' and the cord was broken into two pieces.This is not a new cord, nor could we tell how old it was because the lot number is not on the actual cord, just the packaging, but it was not new." a delay of three minutes was also reported.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
This adverse event is filed under aic reference (b)(4).The sample was submitted to the manufacturer for evaluation.The returned sample showed signs of prior use.The monopolar plug was separated near the strain relief at the instrument end of the cord, and the internal conductor exhibited heat damage.Lot information was not provided, so the exact age of the cord could not be determined, and a device history record (dhr) review was not possible.Based on the cord's condition, it appeared that the sample has been used multiple times.Based on the investigation findings, the reported issue most likely resulted from improper handling and/or use beyond life expectancy.If the cord is removed from the surgical instrument by pulling on the cord rather than the plug, it can weaken over time.This can also happen at the end of the strain relief with repeated use.Over time, this can weaken the internal conductors, leading them to break.Eventually, there are only a few conductors holding the connection together.When the same amount of current is pushed through fewer conductors, heat will be generated which can cause the remaining conductors to burn and break.As a result, the reported failure could not be confirmed to be a manufacturing related issue.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: AESCULAP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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 ; 8334251464
• MDR Report Key: 24269437
• Report Number: 2916714-2026-00004
• Device Sequence Number: 21500126
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: (01)04046964582820
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K913514
• 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): 03/19/2026

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: US354
• Device Catalogue Number: US354
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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