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

Catalog Number 0703047002

Device Problem Unintended Power Up (1162)

Patient Problem Burn(s) (1757)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that during a c-section procedure, the e-sep pencil was running while plugged in but without anyone using it.The user noted burns to both themselves and the patient.The patient was seen by eterostomal wound care and follow up.It was also reported that there were no delays as a result of this event.It was further reported that the procedure was completed successfully.Awaiting further information on the severity of the burn.

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device not returned.

Manufacturer Narrative

H2: this mdr report # 0001811755-2022-00050 is a duplicate of 0001811755-2022-00030.

Event Description

It was reported that during a c-section procedure, the e-sep pencil was running while plugged in but without anyone using it.The user noted burns to both themselves and the patient.The patient was seen by "enterostomal" wound care and follow up.It was also reported that there were no delays as a result of this event.It was further reported that the procedure was completed successfully.Awaiting further information on the severity of the burn.

• Brand Name: SMOKE EVAC. PENCIL COATED RS,NON-STERILE
• 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: 15562210
• MDR Text Key: 303403807
• Report Number: 0001811755-2022-00050
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 37613327379472
• UDI-Public: 37613327379472
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703047002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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