MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER UROVAC¿ BLADDER EVACUATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0067301250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a urovac bladder evacuator was used in a procedure on an unknown date.According to the complainant, a yellow stain was noted on the product.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.

• Brand Name: UROVAC¿ BLADDER EVACUATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7285667
• Report Number: 3005099803-2018-00496
• Device Sequence Number: 16623761
• Product Code: KOG
• UDI-Device Identifier: 08714729753018
• UDI-Public: 08714729753018
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K880099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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 Expiration Date: 07/18/2021
• Device Model Number: M0067301250
• Device Catalogue Number: 730-125S
• Device Lot Number: 20908244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1