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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported to aesculap inc.That a monopolar cable (part # us354) was used during laparoscopic cholecystectomy procedure performed on (b)(6) 2021.According to the complainant, while the surgeon was cauterized laparoscopically, the cord on a hand held device broke off.Reportedly, sparks were observed and a sizzling sound was heard, which was followed by an audible "pop" and the cord breaking off.The equipment and the instrument were exchanged,and then the procedure was continued and completed without further issue.The reporter noted a surgical delay of approximately fifteen (15) to twenty (20) minutes.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Additional information was not provided.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Additional information: b1, b2,b5 & h1 investigation results: the complaint device was forwarded to the manufacturer for evaluation.- visual inspection revealed an insulation break bear the proximal end of the cord.The insulation had entirely burned through.-the wiring in the cord was found to be highly oxidized all along the cord.Device history review: -the lot number of this cord was not provided and a review of the batch history was not possible.Evaluation summary: -tthe amount of oxidation along the wiring suggests the cord has been steam sterilized beyond its life expectancy.-there is no evidence to suggest any defect in design, materials or workmanship.Root cause: - the root cause was that this cord had simply been stream sterilized beyond its life expecetancy which caused it to fail in this manner.Further actions are not required.
Event or Problem Description
While the surgeon was cauterizing laparoscopicly cholecystectomy, the procedure was stopped for 15-20 minutes, while equipment was exchanged.

• 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
• MDR Report Key: 12387714
• Report Number: 2916714-2021-00169
• Device Sequence Number: 4687521
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other