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

Model Number	US354
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (part # us354) was used during a procedure on (b)(6) 2023.According to the complainant the item glowed and smoked but there was no visual sign of damage.A delay in surgery was reported but not specified how long.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Updated information: d9: device returned.Investigation results: one (1) sample provided was returned to the manufacturing site for technical evaluation.Results of the investigation determined visually just beyond the strain relief of the plug, there appears to be a significant kink in the cord.When gently pulling the cord, the wires within the outer casing have separate.Most commonly, the root cause of this issue is related to user handling, the product being used beyond life expectancy, or a combination of user handling and the product being used beyond life expectancy.Without a lot number the age of the cord was unable to be determined and therefore it cannot conclusively say the device had been used beyond its expected life.However, the damage to the cord near the plug's strain relief supports the theory that the cord was mishandled- most likely from being removed from the generator incorrectly.Based on the investigation findings, the smoking and glowing chord most likely resulted from mishandling.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: 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: 17548906
• Report Number: 2916714-2023-00085
• Device Sequence Number: 6683864
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 02/06/2024
• 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