MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMOKE EVAC. PENCIL COATED PB,NON-STERILE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703046002
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
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.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
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.

• Brand Name: SMOKE EVAC. PENCIL COATED PB,NON-STERILE
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11931200
• Report Number: 0001811755-2021-00769
• Device Sequence Number: 3831459
• Product Code: GEI
• UDI-Device Identifier: 37613327379489
• UDI-Public: 37613327379489
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 02/01/2023
• Device Catalogue Number: 0703046002
• Device Lot Number: 2008023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1