MAUDE Adverse Event Report: GYRUS ACMI INC. DURABLE FLEXIBLE URETEROSCOPE

Model Number DUR-8ULTRA

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.The instruction manual warns users: "before removing the endoscope from the patient, be sure the shaft is straight (non-deflected) by utilizing an x-ray (fluoroscopy) device.Patient injury and possible damage to the instrument could result.If the scope is deflected, it may be necessary to withdraw it slightly to straighten the tip, advance the accessory to the distal tip, reposition the scope, and then slowly advance the accessory.".

Event Description

Olympus received a voluntary medwatch form from the user facility which reported that: "patient underwent a right ureteroscopy with laser lithotripsy, complicated by a broken flexible ureteroscope with retained fragment within the right ureter requiring an open ureterectomy with removal of the foreign body and closure of the ureterostomy over a stent.Admitted to the hospital post-op.Dr.Cohen had extended the scope up into the kidney and while once the stone was broken up.Surgeon experience difficulty when withdrawing the flexible scope in the area of the mid to distal ureter.With gentle traction it would not budge.With increased attention to the scope then tore and the access sheath and wire came out with the portion of the scope.On fluoroscopy we were able to see the distal portion which was the flexible portion of the scope there was approximately 4cm in length in the area of the right distal ureter and intramural portion of the right distal ureter.I attempted multiple times to place ureteroscope up into this area and grasp it but due to the tight fit of the scope in the ureter i was unable to remove any significant portion of it this way.We then placed a 27 resectoscope with a collins knife and unroofed the intramural portion of the ureter to expose more of the flexible ureteroscope tip that had broken off.I was able to grasp this multiple times but because it was on the flexible portion of the ureteroscope small pieces of a breaking off.Eventually access to the portion of the scope that was stuck in the ureter was lost and could not unroof the bladder anymore at this time.An exploratory laparotomy was done to do this in a retroperitoneal fashion." olympus followed up with the user facility and was informed that the patient had a stent placed on (b)(6) 2015.The patient returned on (b)(6) 2015 and the stent was replaced due to significant scarring of the ureter.It was stated that there was no medication provided to the patient after the office visit.The patient is scheduled for a follow-up surgical procedure on (b)(6) 2015.The user facility also stated this was an isolated incident.The scope and the device fragments were retrieved from the patient after the procedure.The scope is with risk management and will be contained in the hospital's evidence cabinet.No further information was provided.

• Brand Name: DURABLE FLEXIBLE URETEROSCOPE
• Type of Device: DURABLE FLEXIBLE URETEROSCOPE
• 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: 5022852
• MDR Text Key: 23797313
• Report Number: 2951238-2015-00354
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUR-8ULTRA
• Device Catalogue Number: DUR-8ULTRA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2012
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 97