MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XP150N

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

A user facility submitted a repair request to the olympus service center, for a gastrointestinal videoscope, having bad angle.Upon inspection and testing of the returned device, foreign material was found clogged in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, due to wear of angle wire, bending angle in up direction did not meet the standard value, due to wear of angle wire, the play of up/down knob out of the standard value, nozzle had foreign objects, due to damage on up/down knob, water tightness lost, light guide lens discolored, objective lens discolored, protector of universal cord on control section side scratched, protector of universal cord on scope connector side scratched, scope connector cover unit scratched, up/down knob corrosion, paint on suction cylinder peeled, lock engagement lever scratched, lock engagement lever knob scratched, right/left knob scratched, connecting tube dented, up/down knob scratched, forceps channel port shaved, switch box scratched, scope cover scratched, switch 3 wear, scope connector scratched, universal cord scratched, grip scratched, control unit discolored, control unit scratched, suction cylinder shaved, due to a pinhole on angle rubber, water tightness lost, bending tube deformed, due to dirt on objective lens, lack of image on the monitor.The faulty parts were replaced, and the device will be returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to b5.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the foreign material was insufficient cleaning.Identification of the material could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

Customer additionally reported that the device was cleaned, disinfected, and sterilized before it was returned to olympus.It was not known when the foreign material adhered to the endoscope.There was no delay in the start of precleaning.The air/water nozzle was flushed with water and air.The nozzle was wiped/brushed with a clean lint-free cloth/brush/sponge.The air/water nozzle was flushed with detergent.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16728125
• MDR Text Key: 313591876
• Report Number: 9610595-2023-06030
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170307478
• UDI-Public: 04953170307478
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051645
• 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,Followup
• Report Date: 05/25/2023

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: GIF-XP150N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2007
• 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