MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. INNER SHEATH RESECTOSCOPE; CYSTOURETHROSCOPE

Lot Number LOT 0123CC

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/31/2015

Event Type  malfunction  

Event Description

Tip of resectoscope fell off into patient's bladder.

• Brand Name: INNER SHEATH RESECTOSCOPE
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo, CA 90245
• MDR Report Key: 5453487
• MDR Text Key: 38771276
• Report Number: 5453487
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2016

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?: No
• Device Operator: Physician
• Device Lot Number: LOT 0123CC
• Other Device ID Number: 26MM SHEATH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1