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

Catalog Number	0279351100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the probe heated up.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the probe heated up.
Additional Manufacturer Narrative
It was confirmed that the device was discarded by the customer and will not be returned.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: suction probe melted.Probable root cause: heat can result from insufficient suction which can result from: inadequate hospital suction, leak, bad connection to hospital suction line, clogging caused by suction path blockage, lower electrode mass due to variation in electrode thickness or opening cut.Use errors: nonbendable probe bent with probe bender, or a bendable probe bent with anything other than the stryker rf probe bender.Probe used as a tool for mechanical displacement of tissue or bone, or to pry or scrub.Probe handle is submerged in liquid or suction tube is cut.Pinch clamps left closed when suction is desired or open if suction is not being used incorrect fluid management.The reported failure mode will be monitored for future reoccurrence.

• 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: 21634491
• Report Number: 0002936485-2025-00205
• Device Sequence Number: 9511060
• Product Code: GEI
• UDI-Device Identifier: 07613327056952
• UDI-Public: 07613327056952
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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