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

Catalog Number 0502990300

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 09/05/2018

Event Type  Injury  

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 Description

It was reported that the patient was burned by the cord during a procedure.

• Brand Name: PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE)
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7924482
• MDR Text Key: 122298911
• Report Number: 0002936485-2018-00627
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 07613327064018
• UDI-Public: 07613327064018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 0502990300
• Device Lot Number: 844270
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other