MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMOKE TELE PENCIL UNCOATED PB; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703046005
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported via medwatch 0501800000-2023-8001: that during a cesarean section procedure, the e-sep pencil wasn't working normally.Once the coag button was used, the device got stuck in coag mode.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : disposition of the product is unknown.
Event or Problem Description
It was reported via medwatch (b)(4) : that during a cesarean section procedure, the e-sep pencil wasn't working normally.Once the coag button was used, the device got stuck in coag mode.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: SMOKE TELE PENCIL UNCOATED PB
• Common Device Name: 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: 16398275
• Report Number: 0001811755-2023-00017
• Device Sequence Number: 5685914
• Product Code: GEI
• UDI-Device Identifier: 37613327466349
• UDI-Public: 37613327466349
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2025
• Device Catalogue Number: 0703046005
• Device Lot Number: 65876792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown