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

Model Number URF-P6R

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, olympus followed-up with the user facility via telephone and in writing in an attempt to obtain additional information regarding the reported event, but no information was obtained. The referenced device was returned to olympus for evaluation. The evaluation, found the bending section was broken with sharp metal exposed from the bending section skeleton. The scope failed the leak test from a hole on the bending section cover. In addition, the image has excessive broke image guide bundle breakage (black dots), the angulation low is below specification. Furthermore, the insertion tube and bending section cover/glues are non-olympus parts/repairs. Based on the evaluation findings, the most probable cause of the reported event could be attributed to improper maintenance and or handling. The user facility declined repairs and the scope was returned to the user facility unrepaired. A review of the scope's instrument history record, indicates the scope was purchased on march 28, 2018 with no repair history. As a preventive measure, the instruction manual states, the probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically following regulations, guidelines, etc. Required of you. An endoscope with an observed irregularity should not be used, but should be inspected by following section 5. 2, ¿troubleshooting guide¿. If the irregularity is still observed after inspection, contact olympus. The instruction manual also provides caution which states, ¿this instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner. ¿.

Event Description

Olympus was informed that the user facility's operating room nurse manager tested the scope prior to use and observed the scope was broken. It was not specified when the breakage occurred. There was no patient involvement reported with the subject scope.

• 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 ; 4089355124
• MDR Report Key: 8434886
• MDR Text Key: 141329818
• Report Number: 2951238-2019-00557
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/21/2019
• 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