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

Model Number URF-P6R

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.The a-rubber was found to have multiple leaks.On removal of the bending section cover (a-rubber) from the bending section, the service technician noted multiple bending support pins were detached, which produced sharp edges that ruptured the a-rubber.This type of physical damage is attributed to mishandling.A review of the device history record found no issues that could have caused or contributed to the reported issues.The ifu includes the following information regarding inspection of the endoscope: ¿inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ in addition, the ifu warns, ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable 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.¿ this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The user facility reported to olympus that the device was leaking from the distal end.The issue was observed during reprocessing of the device.There was no patient involvement.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10992946
• MDR Text Key: 220982264
• Report Number: 8010047-2020-10242
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2018
• 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