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 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device was continuously activating.

Event Description

It was reported that the device was continuously activating.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: remains continuously activated while the surgeon does not press the button.The probable root cause/s could be a probe short due to a fluid ingress, or an internal leak due to a broken/damaged bond of the suction tubing.The failure mode will be monitored for future reoccurrence.

• 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: 16024091
• MDR Text Key: 306999473
• Report Number: 0002936485-2022-00777
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057027
• UDI-Public: 07613327057027
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0279401100
• Device Catalogue Number: 0279401100
• Device Lot Number: 22126AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2022
• 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