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

Model Number 0279351400

Device Problems Continuous Firing (1123); Self-Activation or Keying (1557)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that the patient was burned.In addition, it was reported that the device was continuously activating.

Manufacturer Narrative

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

Event Description

It was reported that the patient was burned.In addition, it was reported that the device was continuously activating.

Manufacturer Narrative

Alleged failure: the rf probe active by itself without push button or footswitch.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be an internal leak due to a broken/damaged bond of the polyimide and suction tubing causing fluid ingress to the pcb which can lead to a short circuit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: 90-S ACCELERATOR
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15651215
• MDR Text Key: 302193269
• Report Number: 0002936485-2022-00609
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057041
• UDI-Public: 07613327057041
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 0279351400
• Device Catalogue Number: 0279351400
• Device Lot Number: 21348AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Sex: Male