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	05/13/2025
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 tip (ceramic portion) was broken.There was no remaining fragment in the patient body.
Event or Problem Description
It was reported that the tip (ceramic portion) was broken.There was no remaining fragment in the patient body.
Additional Manufacturer Narrative
Alleged failure: the tip (ceramic portion) was broken.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause of this issue could be attributed to excessive force applied by the user, coupled with inadequate suction during use.It is possible that the unit came into contact with another hard object or device during surgery or while the probe was being inserted or removed in an obstructed passageway, which could result in insulation damage.The device was returned without its original packaging, and there was no lot number marked on the product.As a result, we could not match the lot number on the complaint record (b)(4) with the returned product.However, the reported failure mode is consistent with the issues observed in the device returned for this event.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22180821
• Report Number: 0002936485-2025-00529
• Device Sequence Number: 12862289
• Product Code: GEI
• UDI-Device Identifier: 07613327056884
• UDI-Public: 07613327056884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 24256AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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