MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH RESECTOSCOPE SHEATH

Model Number EIS HCF25

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/31/2018

Event Type  Injury  

Event Description

During procedure for cystoscopy, surgeon noted plastic tip of resectoscope broke off.Surgeon was able to retrieve broken tip.No procedure complications noted and no harm to the pt.Fda safety report id# (b)(4).

• Brand Name: RESECTOSCOPE SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL PRODUCTS CZECH
• MDR Report Key: 8487031
• MDR Text Key: 141105323
• Report Number: MW5085596
• Device Sequence Number: 0
• Product Code: FDC
• Combination Product (y/n): N
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIS HCF25
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 84 YR
• Patient Weight: 58