MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHEATH, STRYKEPROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0250070460
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device caught on fire.
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.
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: thermal event.Probable root cause: generator power malfunction.Material/design error.Conductive irrigant used.User error.The reported failure mode will be monitored for future reoccurrence.Note: the investigation was previously closed based on product not received.However, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: per rep, product caught on fire in the or.Rep would like a report back to see if it was actually this product that caused it.Account is using obsolete bovie consoles.Bought new consoles but have not used probes with new consoles.No patient harm no adverse consequences no medical intervention.The probe did not catch fire in a patient.Cautery was not being activated when this happened outside of the patient.Account said out of the corner of their eye they saw a flame.The failures identified in the investigation is consistent with the complaint record.The probable root causes could be 1.Conductive irrigating or aspirating fluid used was inside the distal end, and contacted the probe and the sheath causing the sheath to melt, 2.Power set too high, 3.User misuse or overuse.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the device caught on fire.

• Brand Name: SHEATH, STRYKEPROBE
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18323173
• Report Number: 0002936485-2023-01248
• Device Sequence Number: 7035003
• Product Code: GEI
• UDI-Device Identifier: 07613327051971
• UDI-Public: 07613327051971
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K963765
• 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): 07/16/2024

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: 0250070460
• Device Lot Number: 102222-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown