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

Model Number URF-P6

Device Problems Device Reprocessing Problem (1091); Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Ess (endoscopy support specialist) performed reprocessing in-service with the staff that included demonstration.Ess recommended that the customer follow all olympus reprocessing procedures as documented in the reprocessing manual.Ess informed the customer that a proper precleaning was needed to be performed according to the olympus ifu (instruction for use).Customer was informed that proper care/handle of the scope was needed to prevent scope damage, explained the importance of each which was acknowledged by staff in attendance.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

As reported, it was determined that during a facility site observation visit, the ess (endoscopy support specialist) determined that the customer was found mishandling the scope during the procedure by letting the insertion tube hanging freely by not protecting the tip.Customer placed scope on table with multiple sharp instruments and with the camera and light guide cable on top of the scope.The customer did not properly preclean the scope with a 30cc syringe.The customer use a 5cc syringe during precleaning.The customer then placed the scope in the transport bin with a telescope and light guide cable and along with other sharp accessories.There was no patient harm or injury reported due to the event.There was no patient infection associated on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, it was determined the cause of the reported event was considered due to use handling, deviation from ifu.As stated on the ifu (instruction for use) the user manual states: important information ¿ please read before use operation manual: 4.5 transportation of the endoscope: transporting within the hospital: when carrying the endoscope by hand, hold the control section in one hand and hold the distal end of the insertion tube securely, but gently without squeezing, in the other hand.Reprocessing manual: 1.4 precautions: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who contact them.Reprocessing manual: 5.1 summary of reprocessing the endoscope: certain accessories are required to manually reprocess the endoscope./ the insertion section of the endoscope is composed of the insertion tube, the bending section, and the distal end.The bending section is covered by a thin, easily damaged elastic covering.Do not allow reprocessing equipment to forcefully contact the bending section.Do not allow any sharp edges, such as the distal ends of endo therapy accessories (needles, forceps, etc.Used in the instrument channel of the endoscope) to contact the bending section.Such improper handling may damage the covering and cause the endoscope to leak.¿ olympus will continue to monitor complaints for this device.

• 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
• MDR Report Key: 12389191
• MDR Text Key: 280585814
• Report Number: 8010047-2021-10976
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1