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

Catalog Number	0279350301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the probe broke during the procedure inside the joint.All pieces were retrieved.
Event or Problem Description
It was reported that the probe broke during the procedure inside the joint.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: back of contour probe (ceramic piece opposite of the face, on distal tip) fell off inside joint the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the probe came in contact with another hard instrument.Excessive force used when inserting or removing the probe, probe inserted into the obstructed passageway or any forceful impact to the tip of the probe with rigid objects.The probe used as a tool for a mechanical displacement of tissue or bone, or to pry or scrub.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: FR 2 PROBES, CONTOUR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8937508
• Report Number: 0002936485-2019-00363
• Device Sequence Number: 2099702
• Product Code: GEI
• UDI-Device Identifier: 07613327056907
• UDI-Public: 07613327056907
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 10/11/2019

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: 0279350301
• Device Lot Number: 18079AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1