MAUDE Adverse Event Report: AESCULAP INC. GOLDTIP BIPOLAR FCPS STR 215/115/2.0MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	US614
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Skin Tears (2516)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
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 goldtip bipolar fcps str 215/115/2.0mm (part # us614) was used during a procedure performed on an unknown date.According to the complainant, the gold coating on the forceps' tip is flaking causing tissue to stick which resulted in tearing/pulling and a restart of bleeding when the device was withdrawn.The complaint device was returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed that the forceps appeared to have heavy usage, despite being approximately one (1) year old.The tips were slightly misaligned.Additionally, the insulation on the working length was faded and scratched indicating that it may have been scrubbed with an abrasive material during use or cleaning, which could also explain why the gold plating was almost entirely worn off of the tips.The loss of gold plating would lead to increased sticking of tissue.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.Based on the investigation results, the most probable root cause was determined to be operational error.

• Brand Name: GOLDTIP BIPOLAR FCPS STR 215/115/2.0MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & 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: 14653307
• Report Number: 2916714-2022-00064
• Device Sequence Number: 4841872
• Product Code: GEI
• UDI-Device Identifier: 04046964161773
• UDI-Public: 4046964161773
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: US614
• Device Catalogue Number: US614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown