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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACMI RIGID CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID

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ACMI RIGID CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID Back to Search Results
Model Number E-123-S
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2019
Event Type  Malfunction  
Event Description

The central service tech was assembling cystoscopy trays and noticed that the black plastic tip located on the distal end of the 17 fr, rigid cystoscope obturator had fallen off. The "tip" assist introducing the rigid cystoscope through the urethra into the bladder. Once the cystoscope is introduced, the obturator with the plastic tip can be removed and the scope with a camera can then be inserted. The safety concern was discovered before the cystoscope obturator was used during a cystoscope procedure. All tips are manually being inspected to ensure that plastic tip can't be removed / pulled off. Olympus medical systems corporation, (b)(4). Fda safety report id# (b)(4).

 
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Brand NameACMI RIGID CYSTOSCOPE
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
MDR Report Key8966016
MDR Text Key158652682
Report NumberMW5089596
Device Sequence Number3
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/03/2019
4 DeviceS WERE Involved in the Event: 1   2   3   4  
1 Patient Was Involved in the Event
Date FDA Received09/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberE-123-S
Device Catalogue NumberE-123-S
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/04/2019 Patient Sequence Number: 1
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