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

Catalog Number	5600180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the bard/davol corbitt spatula distal electrode tip broke off during the procedure and was retrieved immediately from the patient.The subject device was discarded by the user facility and was not available for evaluation.Based on the information provided and not having the sample to evaluate, no definitive conclusions can be made as to why the issue presented.To date, this is the only reported complaint for this manufacturing lot.The instructions-for-use (ifu) supplied with device states: "bending of the electrosurgical tip on this product may damage and/or shorten its life.Do not bend the electrosurgical tip." should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported via fda 3500a form report ((b)(4)): " during laparoscopic cholecystectomy, surgeon using spatula tip cautery to remove gallbladder.Tip broke off the spatula.Tip retrieved immediately with no harm to patient." addendum per additional information: as reported, the bard/davol corbitt spatula distal electrode tip had been locked securely into place and was used for approx.20 minutes prior to "breaking off." another tip was used to complete the case.No alleged patient injury was reported as a result of the problem experienced.

• 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
• MDR Report Key: 11826380
• Report Number: 1213643-2021-20116
• Device Sequence Number: 14469616
• Product Code: GEI
• UDI-Device Identifier: 00801741077210
• UDI-Public: (01)00801741077210
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 01/28/2026
• Device Catalogue Number: 5600180
• Device Lot Number: DAFBAT01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2021
• 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
• Patient Age: 30 YR