MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 DAVOL ADVANTAGE ELECTROSURGICAL ATTACHMENTS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	5600240
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the bard/davol j-hook electrosurgical reusable tip (which requires reprocessing cleaning/sterilization between cases) was used and sterilized 3 times prior to noting the rubber sheath around the tip was separated.As reported, there was no issue with the device during usage and no reported patient injury.As reported, the user facility has not made changes to the sterilization process.
Additional Manufacturer Narrative
As reported, the reusable bard/davol j-hook electrosurgical tip was damaged after 3 uses.The subject device was returned for evaluation.Evaluation of the sample and photos provided finds that the coating on the distal tip is damaged and the insulation sheath coat which covers the metal below the active tip were torn in two areas.The device was used three (3) times before the damage presented; as such, was not an out of box condition and no manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause of the event is determined to be inadvertent damage, most likely presenting during sterilization /cleaning process at the user facility.To date, this is the only reported complaint for this manufacturing lot.

• Brand Name: DAVOL ADVANTAGE ELECTROSURGICAL ATTACHMENTS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): ATC TECHNOLOGIES -1225798; 30-b upton drive; wilmington MA 01887
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14106357
• Report Number: 1213643-2022-00152
• Device Sequence Number: 4776134
• Product Code: GEI
• UDI-Device Identifier: 00801741077234
• UDI-Public: (01)00801741077234
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K003674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2025
• Device Catalogue Number: 5600240
• Device Lot Number: DAEWAT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/13/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown