MAUDE Adverse Event Report: O&M HALYARD, INC. VARV043-05 PLASTICS BREAST TRAY; CAUTERY W/SMOKE TUBING

Model Number	5311356
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 18june2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avid medical complaint database as complaint (b)(4)and the o&m halyard adverse event assessment process as record (b)(4).
Event or Problem Description
Complaint # (b)(4) cautery piece broke off during surgical procedure.This is the 3rd incident that occurred with the bovie.The broken cautery did not fall into the surgical site.It did not increase surgery time.The nursing team had to replace the bovie.Avid medical received a complaint on 06/08/2021, stating that while using the bovie suction, the suction piece broke off during the procedure.The customer stated that the bovie functioned well during most of the case, but failed after several hours.No patient injury was reported.
Additional Manufacturer Narrative
The product involved in the report was not returned for evaluation.A customer complaint was received on the cautery w/smoke tubing, item number 5311356.A supplier corrective action request) was submitted to covidian who assembles this component.The root cause of the failure was not identified.According to covidian, there has been no change to the specifications or the supplier.Their investigation also revealed that there has not been a reported occurrence for the same issue during the past 5 years.Without additional information on the actual use and additional manufacturing steps; i.E.Placement of the sponge with ring and the forces the ring endured during the kitting and packaging process, they are unable to determine a root cause.The incident was also investigated at avid, who does the kitting of this component into their kits and there were no anomalies found in the kitting process as it followed normal procedures and inspections.All information reasonably known as of 26aug2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avid medical complaint database as complaint # (b)(4) and the o&m halyard adverse event assessment process as record ch-dt-2021-a1-35.

• Brand Name: VARV043-05 PLASTICS BREAST TRAY
• Common Device Name: CAUTERY W/SMOKE TUBING
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• MDR Report Key: 12040642
• Report Number: 1047429-2021-00005
• Device Sequence Number: 19888184
• Product Code: GEI
• UDI-Device Identifier: 10809160205099
• UDI-Public: 10809160205099
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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 Model Number: 5311356
• Device Catalogue Number: 20809160205096
• Device Lot Number: 1418072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1