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

Model Number URF-P6R

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation confirmed the reported device damage.The skeleton was found broken and exposed/protruding from the bending section cover; however, the distal end cover was still intact.The scope failed leak testing due to a cut on the bending section cover.In addition, the bending section cover was removed and found the bending section skeleton broken below the insertion tube.The device was serviced and returned to the user facility.The cause of the broken skeleton could not be determined; however, this type of bending section damage is attributed to excessive force.The instruction manual for use states, "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿.

Event Description

Olympus was informed that during an unspecified procedure, the scope became bent and did not work properly.No detachment of the device or device component occurred.There was no patient injury reported.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6363215
• MDR Text Key: 68471271
• Report Number: 2951238-2017-00129
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK912120
• 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
• Report Date: 02/27/2017

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: URF-P6R
• Device Catalogue Number: URF-P6R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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