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

Catalog Number	0279350501
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: outer layers of wands broke.Probable root cause: tip breaking due to design or manufacturing of electrode or ceramic: electrode design; welded electrodes- incomplete weld, weld too small, not located correctly mim; electrodes-variability in electrode material mixture, internal micro cracks, excessive re-grind, tool wear or rework; laser-variation in cnc control, loose threads or motor off, or laser focus off etch-over or under-etching voids in ball-forming process; ceramic design: variation in material mixture of ceramic, manufacturing workmanship errors, excessive glass binders leading to fractures; use error.The device manufacture date is not known.
Event or Problem Description
It was reported that the outer layer of the wand broke during a procedure.All pieces were removed and the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: outer layers of wands broke.Probable root cause: tip breaking due to design or manufacturing of electrode or ceramic: electrode design welded electrodes- incomplete weld, weld too small, not located correctly mim electrodes-variability in electrode material mixture, internal micro cracks, excessive re-grind, tool wear or rework laser-variation in cnc control, loose threads or motor off, or laser focus off etch-over or under-etching voids in ball-forming process ceramic design: variation in material mixture of ceramic, manufacturing workmanship errors, excessive glass binders leading to fractures use error.The device manufacture date is not known.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the outer layer of the wand broke during a procedure.All pieces were removed and the procedure was completed successfully.

• Brand Name: RF 2 PROBES, HOOK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7545556
• Report Number: 0002936485-2018-00460
• Device Sequence Number: 217472
• Product Code: GEI
• UDI-Device Identifier: 07613327056938
• UDI-Public: 07613327056938
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 0279350501
• Device Lot Number: 1801CE212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR