MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 70MM NEEDLE ELECTRODE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703007070
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
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 that expired stryker product was shipped to the customer.It was also reported that this event did not occur during a surgical procedure, and there was no delay, no medical intervention and no adverse consequences as a result of this event.
Additional Manufacturer Narrative
D4: full udi added.D9: product returned to venlo.H6: the quality investigation is complete.
Event or Problem Description
It was reported that expired stryker product was shipped to the customer.It was also reported that this event did not occur during a surgical procedure, and there was no delay, no medical intervention and no adverse consequences as a result of this event.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
This supplemental report is being submitted to capture that this event is not reportable.Upon further investigation, it was determined that this event is unlikely to result in a serious injury.

• Brand Name: 70MM NEEDLE ELECTRODE
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 19750265
• Report Number: 3015967359-2024-01260
• Device Sequence Number: 6586252
• Product Code: GEI
• UDI-Device Identifier: 07613327297812
• UDI-Public: (01)07613327297812(10)1920024)(17)220514
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 05/14/2022
• Device Catalogue Number: 0703007070
• Device Lot Number: 1920024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 04/29/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 11/14/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2019
• 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