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 09/06/2023

Event Type  Injury  

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.There was an inadvertent superficial bovie injury to skin on the left lower quadrant (llq); repaired with 4-0 monocryl suture and sterile dressing applied.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

H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation device is 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.There was an inadvertent superficial bovie injury to skin on the left lower quadrant (llq); repaired with 4-0 monocryl suture and sterile dressing applied.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.

• 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: 17949199
• MDR Text Key: 325835314
• Report Number: 0001811755-2023-00164
• 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