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

Catalog Number 0703046000

Device Problem Unintended Power Up (1162)

Patient Problem Burn(s) (1757)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded.

Event Description

Per medwatch report (b)(4); it was reported that during an abdominal mass removal procedure, the e-sep pencil activated while not in use.It was also reported that this resulted in a small burn on the abdominal wall of the patient.This burn required excision and repair with sutures with local anesthetic.There has been no report of infection.It was further reported that the procedure was completed successfully.

Event Description

Per medwatch report ((b)(4)); it was reported that during an abdominal mass removal procedure, the e-sep pencil activated while not in use.It was also reported that this resulted in a small burn on the abdominal wall of the patient.This burn required excision and repair with sutures with local anesthetic.There has been no report of infection.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6: the quality investigation is complete.

• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15577422
• MDR Text Key: 301583248
• Report Number: 0001811755-2022-00053
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703046000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• 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
• Patient Outcome(s): Required Intervention