MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. INNER SHEATH; CYSTOURETHROSCOPE

Catalog Number 27040 XA

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2021

Event Type  malfunction  

Event Description

During a transurethral resection of prostate (turp), the tip of the inner sheath became dislodged and broke intra-operatively and was embedded in the patient's tissue within the operative site.All fragments were removed per the operating md intra-operatively.Procedure was completed successfully with no injury.Fda safety report id # (b)(4).

• Brand Name: INNER SHEATH
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.
• MDR Report Key: 11435257
• MDR Text Key: 238866460
• Report Number: MW5099830
• Device Sequence Number: 1
• Product Code: FBO
• 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: 03/03/2021

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 Catalogue Number: 27040 XA
• Device Lot Number: WP09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• 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: 77 YR