MAUDE Adverse Event Report: RESECTOSCOPE

Model Number 241290

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 01/12/2018

Event Type  malfunction  

Event Description

The loop of the resectoscope dislodged.It was easily retrieved.

• Brand Name: RESECTOSCOPE
• Type of Device: RESECTOSCOPE
• MDR Report Key: 7233761
• MDR Text Key: 98877458
• Report Number: MW5075010
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 01/30/2018

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
• Device Operator: Health Professional
• Device Model Number: 241290
• Device Lot Number: UMLA01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR