MAUDE Adverse Event Report: KARL STORZ WORKING ELEMENT, MONOPOLAR, 24FR; MONOPOLAR WORKING ELEMENT

Model Number R27050E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Tissue Damage (2104)

Event Date 03/21/2019

Event Type  Injury  

Event Description

Resectoscope loop came loose from working element and lodged in the pt's urethra requiring a forceful removal that resulted in a urethral tear.

• Brand Name: WORKING ELEMENT, MONOPOLAR, 24FR
• Type of Device: MONOPOLAR WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ; southbridge MA
• MDR Report Key: 8528551
• MDR Text Key: 142471574
• Report Number: 8528551
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2019

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: R27050E
• Device Lot Number: LF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 90