MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, LATERAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	0279350201
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2020
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 was continuously activating and had insulation damage.
Event or Problem Description
It was reported that the device was continuously activating and had insulation damage.
Additional Manufacturer Narrative
Alleged failure: the black insulation was damaged and broken.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the unit could have been scrapped with another hard object or device during surgery, or when inserting or removing the probe into an obstructed passageway, which could cause the insulation damage.The probe not used with proper irrigation leading to excessive heat generation.The device manufacturer date is not known.

• Brand Name: RF 2 PROBES, LATERAL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9787353
• Report Number: 0002936485-2020-00114
• Device Sequence Number: 16831915
• Product Code: GEI
• UDI-Device Identifier: 07613327056914
• UDI-Public: 07613327056914
• Combination Product (Y/N): N
• PMA/510(K) Number: K071859
• 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): 04/30/2020

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: 0279350201
• Device Catalogue Number: 0279350201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1