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

Catalog Number 0703046000

Device Problems Fracture (1260); Sparking (2595)

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

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be filed once the quality investigation is complete.Awaiting device return.

Event Description

It was reported that during a procedure, the pencil tip sparked and broke off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

B5: customer confirmed pencil tip did not break, it sparked.H6: device code updated h6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation if device is available.

Event Description

It was reported that during a procedure, the pencil tip sparked and broke off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.It was subsequently reported that the pencil tip did not break, it sparked during a plastics closure after a spine case.

Event Description

It was reported that during a procedure, the pencil tip sparked and broke off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.It was subsequently reported that the pencil tip did not break, it sparked during a plastics closure after a spine case.

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: 15945874
• MDR Text Key: 305183479
• Report Number: 0001811755-2022-00069
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

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: 0703046000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 01/20/2023; 06/28/2023
• Supplement Dates FDA Received: 02/09/2023; 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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