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); Device Remains Activated (1525)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

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

It was reported that during a procedure the e-sep pencil was activated, without the button being pushed, when it was plugged in.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a procedure the e-sep pencil was activated, without the button being pushed, when it was plugged in.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• 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: 17772969
• MDR Text Key: 323717822
• Report Number: 0001811755-2023-00123
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 37613327117203
• UDI-Public: 37613327117203
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K143145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703047000
• Device Lot Number: 66599251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2022
• 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