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

Model Number GIF-1200N

Device Problem Partial Blockage (1065)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during reprocessing (preliminary cleaning and brushing), the tip of the single use combination cleaning brush broke off inside the gastrointestinal videoscope body forceps channel.As reported by the customer, "the cleaning brush is used repeatedly until the brush breaks." it is believed that the broken brush tip may remain inside the scope forceps channel in the customer's user stock of the two (2) gastrointestinal videoscopes identified.The procedure was a diagnostic upper endoscopic screening test.The reprocessing steps that were used on the scope were: bedside washing, aw (air/water) washing adapter use, external surface washing, brush insertion at the sink, and cleaning and disinfection with oer 3/5 solution.Patient identifier: (b)(6) (bw-412t/single use combination cleaning brush/serial number: unknown).Patient identifier: (b)(6) (gif-1200n/gastrointestinal videoscope/serial number: (b)(4).

Manufacturer Narrative

The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 reported brush tip broken off in the forceps channel could not be reproduced; no foreign objects/brush tip were found to remain in the instrument channel, the suction cylinder, or the suction channel of the device.The reported event could not be confirmed.In addition, the following non-reportable malfunctions were found during the device evaluation: - bending section cover (a-rubber) pinhole.Olympus will continue to monitor field performance for this device.

• 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: 16340281
• MDR Text Key: 309609291
• Report Number: 9610595-2023-02147
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2021
• 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: BW-412T/SINGLE USE COMBINATION CLEANING BRUSH