MAUDE Adverse Event Report: GYRUS ACMI INC ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR

Model Number ERVO-CF25

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.The reported phenomenon which stated that the white tip of the device came off after placing in the bladder was not confirmed.A visual and mechanical testing was performed.The release button was found to be loose from the lock ring and pin assembly.The o-ring was also missing from the lock body causing the device to fail the leak test.This could be attributed to normal wear of the device.The instruction for use states, "examine the device prior to use.Do not use if damage is found.".

Event Description

Olympus was informed that during an unspecified procedure, the white tip of the device came off after placing in the bladder.No further information was provided.Olympus made multiple attempts to obtain additional information via telephone and in writing, but with no success.

• Brand Name: ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR
• Type of Device: ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4922966
• MDR Text Key: 22457372
• Report Number: 2951238-2015-00305
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Report Date: 07/02/2015

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 Model Number: ERVO-CF25
• Device Catalogue Number: ERVO-CF25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1