MAUDE Adverse Event Report: AESCULAP INC. MONOPOLAR CABLE W/LG PIN, 10 FEET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	US354
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
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 bipolar fcps rndmicrostr.7mm153mm (part # us345) was used during a laparoscopic on (b)(6) 2025.According to the complainant the chord was broke while plugged in.Reportedly the staff caught bit of cord that sparked there was no injury, fire or delay of case.
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.Item number corrected: d4, g4 510k number updated.Additional information: d9: device returned to manufacturer.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).One (1) sample provided was returned to the manufacturing site for technical evaluation.Results of the investigation determined visually that the cord was found to be broken just outside the strain relief on the instrument end, with visible signs of conductor burn.The condition of the cord suggests it has likely been used several times.Without lot information it is difficult to tell the age of the cord exactly.The likely cause of the failure is either possible misuse or use beyond life expectancy.If the cord is removed from the surgical instrument by pulling the cord rather than the plug, the cord will weaken over time.This can also happen at the end of the strain relief if the cord has been used enough.As the cord weakens, the conductors are broken.Eventually, there are only a few conductors holding the connection together.When the same amount of current is pushed through less conductors, heat will be generated and that can cause the final conductors to burn and break.It is most likely that the failure of this device was the result of life expectancy and a possible user handling issue.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• 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: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22158037
• Report Number: 2916714-2025-00029
• Device Sequence Number: 7505938
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: (01)04046964582820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/20/2025; 08/04/2025
• 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
• Patient Sex: Unknown