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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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 an unspecified date.According to the complainant the cord sparked during the procedure.The adverse event is filed under aic reference (b)(4).
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
Investigation complete.
Additional Manufacturer Narrative
Investigation results: visual inspection observed that the male plug was entirely separated from the wire at the end connecting to the generator.Cutting away a small section of cord revealed that the copper wires were kinked and strained in the area of failure.The overall appearance of the cord suggests the cord has been heavily used.Given the visible condition of the cord and the location of the failure, it is highly likely that the defect condition is the result of misuse.Most likely, the cord was removed from the generator incorrectly.

• 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 ; GM 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: 16994710
• Report Number: 2916714-2023-00059
• Device Sequence Number: 11607377
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 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: 05/05/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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