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

Model Number GIF-H170

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the gastrointestinal videoscope had reduced angulation.This issue was detected during preparation prior to diagnostic procedure.The procedure was completed with a similar device.No adverse effects to patient reported.The device was returned to olympus for evaluation.During evaluation, residue and foreign material was identified in the suction cylinder.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The customer's reported issue of reduced angulation was confirmed; this was caused by a worn angle wire.The worn angle wire also caused excess play in the up/down directional knob.During evaluation, the following issues were identified: the image showed a white scratched area due to a broken charge-coupled unit; the light guide was dim due to a fold in the light guide bundle; the charge coupled device lens was broken; the light guide lens was broken and discolored; the bending section cover adhesive was broken; the connecting tube was dented and corrugated; switch button 1 was deformed; the nozzle flow rate did not meet standards due to a deformed air/water nozzle; the connector cover was scratched which caused the distal end insulation resistance to fail specifications testing; and the suction cylinder did not meet with functional specifications due to a peeling suction cylinder.Finally, the device failed leak testing due to damage to several areas (bending section cover, right/left directional knob, up/down directional knob and the suction cylinder).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was confirmed - however, the foreign material in the suction connector was unable to be further specified.Moreover, no deformation/physical damage of the suction connector was observed, nor was any obvious deviation of reprocessing.Therefore, the cause of the remaining foreign material could not be presumed from the obtained information.Detection methods are written in the following items of the instruction for use (ifu): operation manual: 3.8 inspection of the endoscopic system: inspection of the suction function operation manual: 3.8 inspection of the endoscopic system: inspection of the instrument channel 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: 17423761
• MDR Text Key: 320042297
• Report Number: 9610595-2023-10828
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112680
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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