MAUDE Adverse Event Report: GYRUS ACMI, INC DUR-8ULTRA URETEROSCOPE

Model Number DUR-8ULTRA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

The dur-8ultra ureteroscope, serial number (b)(4) and three small plastic containers that contained various pieces from the physical device was returned to the service center for evaluation.A visual inspection was performed on the received device and noted that the scope parts separated in the container are; pieces of the flexible shaft sheath covering and some portions of the metal structure of which it covers.The internal elements at the distal end are also exposed, due to the separation of the distal end portion of the flexible shaft.It was noted that 55mm of the shaft was broken off.There was foreign material located inside the working channel, and on the flexible shaft.The deflection cover that is supposed to be located at the distal end of the flexible shaft, which is now detached, is also wrinkled and bunched up.Due to the received condition of the scope, it could not be determined as to whether, or not, if there are any missing pieces.The scope could not be functionally tested due to its received biohazard condition and damaged flexible shaft.A review of the instrument history revealed the scope was purchased on (b)(6) 2012, and no record of service was found.The original manufacturer performed a review of the dhrs for this product.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

Event Description

The initial report was filed in the manufacturer¿s legacy system on (b)(6) 2015, please reference mfr.Number: 2951238-2015-00354.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.A review of manufacturing records was performed and showed this model has been obsolete since 2013.This device model was last sold on 31 mar 2013.The oem reported difficulties with inserting and removing the device are a known failure mode.The detachment of components is also a known failure mode.However, the root cause for the known failures does not align with this complaint.The root cause of this event could not be determined.

Manufacturer Narrative

This supplemental report is being submitted to report additional information obtain in medwatch# 5094090.The medwatch states that the patient¿s ureter became obstructed and infected, and subsequently required multiple surgeries and procedures to repair the damage caused.

• Brand Name: DUR-8ULTRA URETEROSCOPE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9738659
• MDR Text Key: 189770676
• Report Number: 2951238-2020-00345
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DUR-8ULTRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1