MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 27FR., .014 WIRE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number	0504881314
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture 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 cutting loop detached from the probe.The detached piece was retrieved.
Event or Problem Description
It was reported that the cutting loop detached from the probe.The detached piece was retrieved.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: electrode would melt the adhesive probable root cause: generator power malfunction , material/design error, conductive irrigant used, improper use with another electromedical device , use error the reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known h3 other text : 81.

• Brand Name: PKG, 90 DEG CUTTING LOOP ELECTRODE 27FR., .014 WIRE
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10847372
• Report Number: 0002936485-2020-00466
• Device Sequence Number: 16867625
• Product Code: FAS
• UDI-Device Identifier: 37613327055512
• UDI-Public: 37613327055512
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040390
• 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): 06/04/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0504881314
• Device Lot Number: STENJC02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1