MAUDE Adverse Event Report: O&M HALYARD, INC. LAKC014-07 EXTREMITY TRAY; 5312752 PENCIL SMOKE EVAC PUSHBUTTON

Model Number 5312752

Device Problem Defective Component (2292)

Patient Problem Burn(s) (1757)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has 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 24 may 2021 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 Description

The customer reported item # (b)(4) pencil smoke evac push button caught fire, exploded and burned the surgeon.No patient injury was reported.The surgeon¿s hand was burned.As of 05/11/2021, still no word from hospital on statement for exact treatment that was performed following the surgeon¿s hand getting burned.No patient injury was reported.

Manufacturer Narrative

The product involved in the report was not returned for evaluation.It was reported that during a total hip procedure, the e-sep pencil caught fire.It was also reported that the surgeon received a burn on the right fore-finger that did not require any medical intervention.The reported event was not confirmed.The suspected device was not available for evaluation.Without having the suspect device, the manufacturer is unable to determine what may have caused or contributed to the reported event.The incident was also investigated at avid, who does the kiting of this component into there kits and there were no anomalies found as the kiting process where it followed normal procedures and inspections.All information reasonably known as of 07jul2021 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-a1-25.This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or caused serious injury.H3 other text : device not returned.

• Brand Name: LAKC014-07 EXTREMITY TRAY
• Type of Device: 5312752 PENCIL SMOKE EVAC PUSHBUTTON
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• MDR Report Key: 11886394
• MDR Text Key: 255794093
• Report Number: 1047429-2021-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10809160313060
• UDI-Public: 10809160313060
• Combination Product (y/n): N
• PMA/PMN Number: K143145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

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
• Device Operator: Health Professional
• Device Model Number: 5312752
• Device Catalogue Number: PENCIL SMOKE EVAC PUSHBUTTON
• Device Lot Number: 1419188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other