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

Catalog Number 0703047000

Device Problems Unintended Power Up (1162); Excessive Heating (4030)

Patient Problem Laceration(s) (1946)

Event Date 05/18/2023

Event Type  Injury  

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

Per medwatch report 1400670000-2023-8004: it was reported that during a procedure the e-sep pencil rocker switch was sensitive and easily activated.The customer also stated they believed that the electrocautery devices are hotter than the previously used electrocautery devices.The patient had a 2cm laceration that required one stitch to repair.The laceration is expected to scar but it is not likely to need additional/continuing treatment.No infection was reported.The procedure was completed successfully without a clinically significant delay.

Manufacturer Narrative

Correction d9/h3: device not available for return.H6: the quality investigation is complete.H3 other text : device not available for return.

Event Description

Per medwatch report (b)(4): it was reported that during a procedure the e-sep pencil rocker switch was sensitive and easily activated.The customer also stated they believed that the electrocautery devices are hotter than the previously used electrocautery devices.The patient had a 2cm laceration that required one stitch to repair.The laceration is expected to scar but it is not likely to need additional/continuing treatment.No infection was reported.The procedure was completed successfully without a clinically significant delay.

• 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 17949962
• MDR Text Key: 325853394
• Report Number: 0001811755-2023-00174
• Device Sequence Number: 1
• Product Code: GEI
• 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
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703047000
• Device Lot Number: 214520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• 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
• Patient Outcome(s): Required Intervention