MAUDE Adverse Event Report: GYRUS ACMI, INC.; URETERSCOPE, FLEXIBLE

Model Number DUR 8

Device Problems Break (1069); Defective Component (2292)

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

Event Date 10/30/2017

Event Type  malfunction  

Event Description

Two separate ureteroscopes noted to be defective.#1-for cystoscopy procedure, right retrograde pyelogram, right ureteral stent placement ureteroscopy, and lithotripsy with laser, a 12mm defect was noticed.The sheath broke and the inner scope/metal was exposed.The scope had been sterilized.#2-a similar defect on the sheath was noted on this second scope on the same date.

• Type of Device: URETERSCOPE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 7074426
• MDR Text Key: 93498462
• Report Number: 7074426
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2017

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: No Information
• Device Model Number: DUR 8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR