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	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.Visual examination found no voids, damage to the insulative materials.The device is in good condition with no anomalies identified.Insulation testing confirmed there were no voids detected in the sample.Based on the sample evaluation and investigation performed, it is determined that the sample returned meets specification.To date, this is the only reported complaint for this manufacturing lot.Note, the date of event is provided as a best estimate based on the awareness date of the reported event.
Event or Problem Description
As reported, the bard/davol j-hook electrosurgical tip (re-usable) failed after 4 uses.As reported, the metal tip is usually 2mm away and there was damage/tears/wear to the insulation coating.It was reported that the device failed the insulation test when tested with an insulation tester.There was no reported patient injury.

• 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: 12806400
• Report Number: 1213643-2021-20409
• Device Sequence Number: 5575426
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 12/28/2023
• Device Catalogue Number: 5600240
• Device Lot Number: DACYAT15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2021
• Initial Report FDA Received Date: 11/12/2021
• 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