MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Code Available (3191)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus for evaluation.The manufacturing record of the device was reviewed with no irregularity found.If additional information becomes available at a later time, this report will be supplemented.

Event Description

The user facility used the subject device to crush a 2cm-sized stone and remove them.After one hour from the start of the procedure, the scope could not be withdrawn, and the ureter had to be incised in order to withdraw the scope.The distal end of the scope was above the bladder.The patient extended the period of hospital stay and left the hospital six days later.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5688018
• MDR Text Key: 46163812
• Report Number: 8010047-2016-00672
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K#: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2016

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: URF-P6
• Device Catalogue Number: URF-P6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• 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): Other