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

Model Number	0279351100
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was burned.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, 7mm extended length endoscope was foggy or blurry while attempting to use for vessel harvesting.The scope has exceeded the one year warranty period.They are attempting to clean the scope further but have been made aware their warranty window has elapsed.No patient harm.
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: smoke came out of the column, we could not identify from which material probable root cause: system design power supply material isolation power failure fuses fail to break circuit due to excessive mains current leading to fire the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15163119
• Report Number: 0002936485-2022-00443
• Device Sequence Number: 12412014
• Product Code: GEI
• UDI-Device Identifier: 07613327056952
• UDI-Public: 07613327056952
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0279351100
• Device Catalogue Number: 0279351100
• Device Lot Number: 21298AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown