MAUDE Adverse Event Report: AESCULAP INC. BIPOLAR FCPS RNDMICROSTR .7MM153MM; BIPOLAR COAGULATION

Model Number	US345
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a bipolar fcps rndmicrostr.7mm153mm (part # us345) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the forceps were sticking while cauterizing, which led to vessel damage.The complaint device was returned to the manufacturer for evaluation.Although requested, no further information has been made available.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed that the tips of the device were charred and pitted.No other damage was noted.The device history records (dhr) were reviewed for the provided serial number; the device was found to be within specification at the time of production.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.Furthermore, although the device condition would make the forceps more likely to stick to issue, the manufacturer makes no claim that the device is non-stick, nor is the device marketed as such.Therefore, based on the investigation results, the most probable root cause was determined to be operational error.

• Brand Name: BIPOLAR FCPS RNDMICROSTR .7MM153MM
• Common Device Name: BIPOLAR COAGULATION
• 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: 15067075
• Report Number: 2916714-2022-00069
• Device Sequence Number: 5711921
• Product Code: GEI
• UDI-Device Identifier: 04046964582509
• UDI-Public: 4046964582509
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K811820
• 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): 03/28/2023

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: US345
• Device Catalogue Number: US345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 03/28/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown