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

Catalog Number	0279351400
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had insufficient / no energy delivered.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device had insufficient / no energy delivered.
Additional Manufacturer Narrative
Alleged failure: the device does not coagulate, does not cut, buttons do not respond.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 reaching the pcb board or, a broken/damaged bond of the suction tubing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: 90-S ACCELERATOR
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20509667
• Report Number: 0002936485-2024-00711
• Device Sequence Number: 18172469
• Product Code: GEI
• UDI-Device Identifier: 07613327057041
• UDI-Public: 07613327057041
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 0279351400
• Device Lot Number: 24050AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown