MAUDE Adverse Event Report: GYRUS ACMI INC UROPASS URETERAL ACCESS SHEATH; UROPASS ACCESS SHEATH

Model Number 61224BX

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If significant information is received or the device is returned at a later date, this report will be supplemented.

Event Description

Olympus was informed that during a therapeutic renal stone removal procedure, the physician experienced resistance when advancing the ureterscope through the sheath.The sheath broke in multiple fragments in the the distal ureter.The physician retrieved all observed fragments using a graspers with the aid of fluoroscopy and direct ureteroscope vizualization.The intended procedure was completed with another similar device.There was no bleeding observed.It was also reported that the device was inspected pre-procedure and no anomaly was noted.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to correct the reported event date from (b)(6) 2016 to (b)(6) 2015 and to provide the device evaluation results.The device was returned to olympus for evaluation.A visual and photographic inspection was performed and confirmed that the white outer sheath was broken.In addition, the photographic images were sent to the original equipment manufacturer (oem) for further investigation and it was determined that the most likely cause of the reported event can be attributed to a product material break down due to excessive exposure to light.

• Brand Name: UROPASS URETERAL ACCESS SHEATH
• Type of Device: UROPASS ACCESS SHEATH
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5393867
• MDR Text Key: 36962408
• Report Number: 2951238-2016-00029
• Device Sequence Number: 1
• Product Code: KNY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61224BX
• Device Catalogue Number: 61224BX
• Device Lot Number: 09A1100334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1