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

Catalog Number	0279251101
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
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 tip of the device breaking during the procedure.The device was only cracked.
Additional Manufacturer Narrative
Alleged failure: the issue was noticed during the surgical procedure when the item was in use- the white sheath at the end cracked.The patient had been given an axillary block and sedation for the procedure (wrist arthroscopy).The consultant said that he did need to use the device for longer than he usually would as this particular case had extensive tissue that need debridement.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force used when inserting removing the probe, probe inserted into an obstructed passageway, or any forceful impact to the tip of the probe with rigid objects, 2) probe used as a tool for a mechanical displacement of tissue or bone, or to pry or scrub.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the tip of the device breaking during the procedure.The device was only cracked.

• Brand Name: RF 2 PROBES AARDVARK
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20864829
• Report Number: 0002936485-2024-00916
• Device Sequence Number: 20975926
• Product Code: GEI
• UDI-Device Identifier: 07613327056884
• UDI-Public: 07613327056884
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 0279251101
• Device Lot Number: 23258AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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