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

Catalog Number 0703047001

Device Problem Arcing (2583)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure an e-sep pencil was being used when it arced, and a surgeon was burned through their glove.The burn was 3mm in size on their forearm.No medical intervention or additional treatment was required and no permanent damage or infection is expected.The procedure was completed successfully without a delay.

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device not available for return.

Event Description

It was reported that during a procedure an e-sep pencil was being used when it arced, and a surgeon was burned through their glove.The burn was 3mm in size on their forearm.No medical intervention or additional treatment was required and no permanent damage or infection is expected.The procedure was completed successfully without a delay.This is 1 of 3 events that occurred at the same account.

Manufacturer Narrative

B5: added the following: "this is 1 of 3 events that occurred at the same account.".H6: the quality investigation is complete.

• Brand Name: ROCKER-SWITCH SMOKE EVAC PENCIL, UNCOATED
• 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18217178
• MDR Text Key: 329934309
• Report Number: 0001811755-2023-00236
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K143145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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: 0703047001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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