MAUDE Adverse Event Report: AESCULAP INC. MONOPOLAR CABLE W/LG PIN, 10 FEET; VISUAL SYSTEMS & EQUIPMENT

Model Number	US354
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
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 (part # us354) was used during a laparoscopic procedure performed on (b)(6) 2022.According to the complainant, during the procedure, an electric discharge was observed where the base of the cord meets the generator.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.However, a surgical delay of between five (5) and ten (10) minutes was noted.The malfunction is filed under aic reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed that the plug was separated from the cord with apparent oxidation along the internal wires, representative of electrical discharge.Functional testing could not be performed due to the separation of the plug.Furthermore, the cord showed evidence of heavy usage with hard bends in the wire near the failure point, which is indicative of improper removal of the cord from the generator.The instructions for use (ifu) document indicates that the cord should be removed from the generator using the base of the plug.Repeated improper cord removal would increase the likelihood of this type of failure.The device history records (dhr) were not able to be reviewed as the lot number was not made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.There was no evidence to suggest any defect in the design, materials, or workmanship of the device.Based on the investigation results, the most probable root cause was determined to be improper user handling.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• Common Device Name: VISUAL SYSTEMS & EQUIPMENT
• 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: 15877301
• Report Number: 2916714-2022-00111
• Device Sequence Number: 2468472
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 11/01/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 02/17/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown