MAUDE Adverse Event Report: GYRUS ACMI, INC FLEXIBLE URETEROPYELOSCOPE KIT; DUR-8LEXIBLE URETEROPYELOSCOPE

Model Number DUR-8

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

The scope will not be returned to olympus as it was sent to third party entity for repair; however, the user facility did provide images of the defect found on the scope¿s outer sheath.Olympus was unable to perform a review of the instrument¿s service history as no serial number was provided.As part of our investigation, a review of the product history was performed using the device model and found that on july 10, 2013, olympus sent out discontinuation notices to customers of the legacy gyrus acmi flexible endoscopes (dur-8).As of may 01, 2013, manufacturing of this model was discontinued and was no longer or sold by olympus.Olympus followed up with the user facility and was informed that the scope was initially acquired from a third party source; therefore, it is unknown if the affected area of the scope is the manufacture¿s organic material.The dur-8 instruction manual provides the user several warnings regarding proper inspection, maintenance and repair of the scope.¿check the outer surface of the flexible shaft prior to each use to make certain that the instrument is free of any cuts, holes, rough surfaces, sharp edges, or protrusions.Do not use if damage is suspected or discovered.Do not modify this device/equipment.Modification of this device/equipment may result in injury to the patient and/or operator, and damage to the equipment and/or peripheral instruments.This device has no serviceable parts.Do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Service warning and disclaimer notice: it is recommended that the medical equipment for which these documents apply be returned to gyrus acmi for servicing or repair.Service or repair provided by any party other than gyrus acmi or a gyrus acmi-authorized repair facility may result in the user and/or repair facility being liable and responsible for damages, including patient or user injuries, arising from such servicing or repair, and any such servicing or repair shall void the manufacturer¿s limited express warranty, if any, applicable to such medical equipment.¿.

Event Description

Olympus received a medwatch report that indicates at the conclusion of a cystoscopy, right retrograde pyelogram, right ureteral stent placement ureteroscopy and lithotripsy with laser procedure; a 12 mm portion of the scope¿s outer sheath was noted to be detached exposing metal.It is unknown if the device fragment fell into the patient.No bleeding was reported.The intended procedure was completed.The patient did not require additional procedures or a longer stay.There was no patient injury reported.

• Brand Name: FLEXIBLE URETEROPYELOSCOPE KIT
• Type of Device: DUR-8LEXIBLE URETEROPYELOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7143739
• MDR Text Key: 96017946
• Report Number: 2951238-2017-00786
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK012925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2017

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: DUR-8
• Device Catalogue Number: DUR-8
• Device Lot Number: N/A
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/22/2017
• 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