MAUDE Adverse Event Report: AESCULAP INC. MONOPOLAR CABLE W/LG PIN, 10 FEET; HIGH FREQUENCY ACCESSORIES

Model Number	US354
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: 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 cable w/lg pin, 10 feet (item # us354) was used in a case on (b)(6) 2022.According to the complainant, the surgical technician added the cord to the device, and then the surgeon placed in position and stepped on the foot pedal.Reportedly, the device immediately popped, with smoke and flames observed.The cord fell from the hub.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The malfunction is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.Visual inspection demonstrated failure of the cord at female end as the plug was detached from the cord.The detached plug was not returned however the fracture point of the cord shows signs of distortion, potentially from mishandling.The exposed wires appear oxidized and wire casing appears thinned and burnt.The wire appears well used and the male end of the cord has wear marks consistent with repeated use.It's possible that the cord was likely used beyond life expectancy, however, without any lot number we are unable to confirm the age of the cord.Given the condition of the cord, the most likely root cause of this complaint is due to misuse.Repeated improper use would increase the likelihood of this type of failure.Based on this evaluation, there does not appear to be any defect in design, materials or workmanship.
Event or Problem Description
Investigation complete.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• Common Device Name: HIGH FREQUENCY 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: 16086361
• Report Number: 2916714-2022-00116
• Device Sequence Number: 13964359
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/24/2023
• 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