MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES HOOK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279350501
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke during the procedure.The pieces were removed from the patient.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: hook broke off probable root cause: non-conforming component, poor assembly process, misuse.Use errors probe used as a tool for mechanical displacement of tissue or bone, or to pry or scrub excessive force used when inserting of removing probe, probe inserted into obstructed passageway, or any forceful impact to the tip of the probe with rigid objects excessive use of device beyond stated lifetime the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device broke during the procedure.The pieces were removed from the patient.

• Brand Name: RF 2 PROBES HOOK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21551350
• Report Number: 0002936485-2025-00181
• Device Sequence Number: 4419723
• Product Code: GEI
• UDI-Device Identifier: 07613327056938
• UDI-Public: 07613327056938
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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 Catalogue Number: 0279350501
• Device Lot Number: 24192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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