MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FORMULA 180 SHAVER INTERNATIONAL KIT.; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 0375708500

Device Problem Smoking (1585)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was a thermal event.Note, it was noticed during inspection.

Event Description

It was reported that there was a thermal event.Note, it was noticed during inspection.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: demo specialist reported that : "we tested an engine back, it made a strange noise, we took it to the ts and the tech gave it back to me and asked me to open a pi.The engine smokes and the consumption is not good." the probable root causes could be 1) suction lever in closed position 2) clogged suction pathway the device manufacture date is not known.

• Brand Name: FORMULA 180 SHAVER INTERNATIONAL KIT.
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12270888
• MDR Text Key: 266841361
• Report Number: 0002936485-2021-00416
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2021

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: 0375708500
• Device Catalogue Number: 0375708500E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 10/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1