MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBE, MICRO-BRUSH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	0279250201
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that unintended material was left in the joint.
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: white band around the end of the probe came off inside the joint.Probable root cause: protective measures: 100% visual inspection info: instructions for use statements: overuse may cause excessive electrode wear.Do not use the probe as a tool for the mechanical displacement of tissue or bone.Do not use excessive force when inserting or removing the probe.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that unintended material was left in the joint.

• Brand Name: RF 2 PROBE, MICRO-BRUSH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9576413
• Report Number: 0002936485-2020-00021
• Device Sequence Number: 2224958
• Product Code: GEI
• UDI-Device Identifier: 07613327056860
• UDI-Public: 07613327056860
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0279250201
• Device Catalogue Number: 0279250201
• Device Lot Number: 19157AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other