MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHEATH, STRYKEPROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	0250070460
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the device arced/sparked.
Event or Problem Description
It was reported that the device arced/sparked.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: sparking.Probable root cause: 1.Generator power malfunction.2.Material/design error.3.Conductive irrigant used.4.Manufacturing / assembly error.5.User error.Lot number is unknown; therefore, manufacture date can not be confirmed.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: SHEATH, STRYKEPROBE
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14240178
• Report Number: 0002936485-2022-00207
• Device Sequence Number: 14751348
• Product Code: GEI
• UDI-Device Identifier: 07613327051971
• UDI-Public: 07613327051971
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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 Model Number: 0250070460
• Device Catalogue Number: 0250070460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown