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

Model Number 0279401100

Device Problem Continuous Firing (1123)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported that the device continuously activated.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: after being turned on, it was stuck on "on" and could not be used anymore.Based on the physical evidence during the investigation, the probable root cause/s could be the fluid ingression into the handpiece due to an internal leak due to a broken/damaged bond on the internal suction tubing.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the device continuously activated.

• Brand Name: RF 2 PROBES, 90-S MAX
• Type of Device: 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: 16161589
• MDR Text Key: 307677912
• Report Number: 0002936485-2023-00022
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057027
• UDI-Public: 07613327057027
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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
• Device Operator: Other
• Device Model Number: 0279401100
• Device Catalogue Number: 0279401100
• Device Lot Number: 22143AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1