MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, 90-S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279351100
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insulation damage resulting in the leakage of electric current.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
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: current leakage.Probable root cause: circuit failure, damage cables, fluid ingress, use error.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was insulation damage resulting in the leakage of electric current.
Additional Manufacturer Narrative
Updated g2 manufacturing site to stryker endoscopy-san jose.Alleged failure: hot leakage phenomenon was found at the contact area between the white plastic head of the device and the metal rod (near the end of the metal rod).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes may include tissue residues trapped between the lumen and the ceramic, which could ignite and create the arcing effect.Other possibilities include inadequate suction during use or an electrical short within the ceramic (this location could not be observed during the visual inspection and would require milling of the ceramic for further verification).The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was insulation damage resulting in the leakage of electric current.

• Brand Name: RF 2 PROBES, 90-S
• 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: 19955615
• Report Number: 0002936485-2024-00548
• Device Sequence Number: 8856295
• Product Code: GEI
• UDI-Device Identifier: 07613327056952
• UDI-Public: 07613327056952
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2025

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: 0279351100
• Device Lot Number: 23178AE2
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 04/08/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/14/2024; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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