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

Model Number GIF-1200N

Device Problems Device Reprocessing Problem (1091); Mechanical Jam (2983)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.However, there was another reportable finding of a foreign object in the device nozzle upon inspection.Other evaluation findings are as follows: the bending angle in the up direction did not meet the standard value due to wear of the angle wire; the play of the upward/downward knob was out of the standard value, also due to wear of the angle wire; the adhesive on the bending section cover had a chip; the adhesive around the light guide lens was peeled; the connecting tube had a dent and discoloration; and the suction connector was dirty due to water leakage.Lastly, there were scratches on the following parts: the bending section cover, the adhesive on the bending section cover, the suction connector, plastic distal end cover, the connecting tube, the scope connector, the scope connector case unit, the forceps elevator lever, the forceps elevator knob, the upward/downward knob, the right/left knob, the universal cord, the grip, the control unit, and the switch box.The foreign material found has been attributed to insufficient cleaning.The customer provided the cleaning, disinfecting, and sterilization process as follows: the device was cleaned, disinfected, and sterilized before it was sent in for repair.The customer checked, but is unsure about the nature of the foreign material.There was no delay in the start of the precleaning and no abnormalities in the accessories used for reprocessing.The customer flushed the air/water nozzle with water and air and wiped/brushed the air/water nozzle with clean lint-free cloths, brush, or sponges.The customer also flushed the air/water nozzle channel with the detergent solution.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, regarding the angulation did not return to the straight, the cause of the event is likely: ·damage on the angulation parts ·deterioration of the angulation mechanism due to rust ·a foreign material got stuck in the movable part in the control section and the angulation control knob became unmovable ·the angulation wire was torn and the distal end section became apart and unmovable.Therefore, the angulation kept engaged.Regarding a foreign material in the nozzle, the cause of the foreign material remaining was unable to be specified.The reprocessing method for the foreign material residue point did not deviate from the instruction manual and the foreign material residue point had no physical damage.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the gastrointenstinal videoscope's angle did not return.The intended procedure was completed and there was no report of patient harm.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17321223
• MDR Text Key: 319752722
• Report Number: 9610595-2023-10089
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2023

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-1200N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• 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
• Treatment: CLV-290-EVIS LUCERA ELITE XENON LIGHT SOURCE; CV-290-EVIS LUCERA ELITE VIDEO SYSTEM CENTER