MAUDE Adverse Event Report: CARL STORZ CARL STORZ RESECTOSCOPE 28F

Model Number 27040XB/X

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2015

Event Type  Injury  

Event Description

Patient is here for a turbt, and during the procedure the patient started bleeding and physician noticed the resectoscope tip broke inside the patient.Surgeon then had to resect the prostate.(b)(4).

• Brand Name: CARL STORZ RESECTOSCOPE 28F
• Type of Device: CARL STORZ RESECTOSCOPE 28F
• Manufacturer (Section D): CARL STORZ
• MDR Report Key: 5273130
• MDR Text Key: 32993618
• Report Number: MW5058345
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2015

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 Model Number: 27040XB/X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR