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

Model Number E-121-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).

• Brand Name: ACMI RIGID CYSTOSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• MDR Report Key: 8966016
• MDR Text Key: 158652682
• Report Number: MW5089596
• Device Sequence Number: 2
• Product Code: FAJ
• 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: 09/03/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E-121-S
• Device Catalogue Number: E-121-S
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 70