MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the uretero-renovideoscope experienced a collapsed image guide coil.It was unknown when the event was identified.There was no report of patient or user harm associated with the event.During testing and inspection of the returned device revealed that the forceps plug mouthpiece was scraped.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation.The customers¿ allegation of collapse, buckling, depression, scratch, cut, wrinkles of the insertion section was confirmed.The connecting tube had a specified dent.Additionally, during inspection and evaluation, olympus identified the forceps channel port was shaved, due to physical stress of the device.The following events were noted in the evaluation and are as follows: (a.) the distal end was burnt, (b.) the adhesive on the bending section cover, or distal end (a-rubber) had a chip, (c.) the universal cord had a scratch, (d.) the protector of universal cord on control section side had a cut, (e.) due to damage on channel tube, forceps cannot be inserted smoothly, this was due to buckling and deformation of the channel, (f.) the control unit, the grip, and the lock engagement lever had a scratch, (g.) the up down plate had discoloration, (h.) the angulation lever had a scratch, (i.) the insertion tube rotation ring had a scratch, (j.) the light guide connector had a scratch, (k.) the video cable had a scratch, (l.) the video connector had a scratch, (m.) and the video connector case had a scratch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon could attributed due to stress of repeated use, external factors, or handling.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17269667
• MDR Text Key: 318885216
• Report Number: 3002808148-2023-06764
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2008
• 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