MAUDE Adverse Event Report: PROSURG/BOSTON SCIENTIFIC STORZ BRAND; SINGLE STEM RESECTOSCOPE

Model Number M0068802030

Device Problems Flaked (1246); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Dr (b)(6) using storz brand single stem resectoscope (mfr: prosurg/boston scientific; catalog number 880-203; product number m0068802030; lot number 0114018; expiration date 01/2017); cst, noticed number and letters floating in the bladder" at end of procedure; when resectoscope removed, letters and numbers were missing from instrument; the numbers and letters appeared to be made of ink only-not printed on plastic or stickers.Reason for use: used during surgical procedure for bladder cancer.

• Brand Name: STORZ BRAND
• Type of Device: SINGLE STEM RESECTOSCOPE
• Manufacturer (Section D): PROSURG/BOSTON SCIENTIFIC
• MDR Report Key: 3788350
• MDR Text Key: 19569908
• Report Number: MW5035874
• Device Sequence Number: 1
• Product Code: FJL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: M0068802030
• Device Catalogue Number: 880-203
• Device Lot Number: 0114018
• Other Device ID Number: *+$ $801011701140184R*
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 75