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

Catalog Number 0703046000

Device Problems Unintended Power Up (1162); Device Remains Activated (1525)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/10/2023

Event Type  malfunction  

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 the e-sep pencil was activating and running during the procedure.The generator, grounding pad and pencil were replaced.It was reported that the holster for the electrocautery pencil was not used consistently during the procedure.Following the procedure, the surgical drape was removed to reveal 2 superficial burns/discolorations from the electrocautery pencil on the right side of the abdomen near the surgical incision.The attending surgeon applied liquiband adhesive to the affected sites.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a procedure the e-sep pencil was activating and running during the procedure.The generator, grounding pad and pencil were replaced.It was reported that the holster for the electrocautery pencil was not used consistently during the procedure.Following the procedure, the surgical drape was removed to reveal 2 superficial burns/discolorations from the electrocautery pencil on the right side of the abdomen near the surgical incision.The attending surgeon applied liquiband adhesive to the affected sites.

• Brand Name: PUSH-BUTTON 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18354892
• MDR Text Key: 330875324
• Report Number: 0001811755-2023-00244
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 37613327117180
• UDI-Public: 37613327117180
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703046000
• Device Lot Number: 64855500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2022
• 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