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

Model Number 0279401200

Device Problem Continuous Firing (1123)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

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

Alleged failure: probe was activated and then operated under continuous fire and could no longer be deactivated.Probe was unplugged.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a probe short due to a fluid ingress, an internal leak due to a broken/damaged bond of the polyimide, and suction tubing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the device continuously activated.

• Brand Name: SERFAS ENERGY 90-S CRUISE
• 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: 16326945
• MDR Text Key: 309159266
• Report Number: 0002936485-2023-00089
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057034
• UDI-Public: 07613327057034
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/12/2023

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: Health Professional
• Device Model Number: 0279401200
• Device Catalogue Number: 0279401200
• Device Lot Number: 22084AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• 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