MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE); CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number	0502990300
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
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: bovie cord broke and patient burned.Probable root cause: insulation melting, excessive cauterization, manufacturing/assembly error, break or crack in cable insulation, use error.The device manufacture date is not known.
Event or Problem Description
It was reported that the patient was burned by the cord during a procedure.

• Brand Name: PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE)
• Common Device Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7924482
• Report Number: 0002936485-2018-00627
• Device Sequence Number: 19182405
• Product Code: FAJ
• UDI-Device Identifier: 07613327064018
• UDI-Public: 07613327064018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/01/2018

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 Catalogue Number: 0502990300
• Device Lot Number: 844270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/01/2018
• 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