MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ROCKER-SWITCH SMOKE EVAC PENCIL, COATED; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number 0703047000

Device Problem Arcing of Electrodes (2289)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.H3: device not available for return.

Event Description

It was reported via medwatch 5115980: that during a lararoscopic cholecystectomy the e-sep pencil was set down in the surgical field and a raytec gauze caught fire.Surgeon said the bovie arced and the raytec caught on fore.The surgeon threw the raytec on the ground and the fire went out.The patient suffered a small burn to the abdomen.The procedure was completed successfully without a delay; no medical intervention was reported.

Event Description

It was reported via medwatch 5115980: that during a lararoscopic cholecystectomy the e-sep pencil was set down in the surgical field and a raytec gauze caught fire.Surgeon said the bovie arced and the raytec caught on fore.The surgeon threw the raytec on the ground and the fire went out.The patient suffered a small burn to the abdomen.The procedure was completed successfully without a delay; no medical intervention was reported.

Manufacturer Narrative

H6: the quality investigation is complete.

• Brand Name: ROCKER-SWITCH SMOKE EVAC PENCIL, COATED
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16816493
• MDR Text Key: 314022521
• Report Number: 0001811755-2023-00072
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 37613327117203
• UDI-Public: 37613327117203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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 Catalogue Number: 0703047000
• Device Lot Number: 08-APR-2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1