MAUDE Adverse Event Report: GYRUS ACMI INC. ROTATING CF RESECTOSCOPE INNER SHEATH; RESECTOSCOPE INNER SHEATH,

Model Number ERIS-CF25

Device Problem Break (1069)

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

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time or if the device is returned, this report will be supplemented accordingly.This type of damage to the sheath is most likely related to the operator's technique.The instruction manual warns users: "always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath's insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.If drag or resistance is encountered during assembly or disassembly, stop-align working element and sheath parallel to one another before proceeding.".

Event Description

Olympus was informed that during a therapeutic trans-urethral resection of the prostate (turp) procedure, the insulated distal tip of the device broke off and fell inside the patient.The reported incident was noted upon withdrawal of the device from the patient.It was reported that the tip was not retrieved due to poor visualization from the prostatic bleeding within the bladder.The physician elected to delay removal of the device fragment to avoid further tissue damage to the operative area and poor visibility was observed.An x-ray was not performed immediately following the surgery.On (b)(6), 2015, an x-ray of kidneys, ureter, and bladder (kub) was performed and no device fragment was found.It was also stated that the patient has been scheduled for a cystoscopy procedure on (b)(6), 2015 for further evaluation.However, there was no patient injury reported.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: RESECTOSCOPE INNER SHEATH,
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5148165
• MDR Text Key: 28253414
• Report Number: 2951238-2015-00416
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Device Catalogue Number: ERIS-CF25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 82