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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.
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key12389191
MDR Text Key280585814
Report Number8010047-2021-10976
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No