MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 12/05/2021

Event Type  malfunction  

Event Description

The customer reported that during a gastroscopy procedure, the scope¿s nozzle was noted to be clogged.There was not more than 15 minute delay.The intended procedure was completed with a similar device.There was no patient injury reported.The scope was returned for evaluation and foreign material was noted exiting the scope¿s channel.This report is being submitted to address the foreign material noted in the channel during the evaluation.

Manufacturer Narrative

The reporter¿s occupation and health profession are unknown at this time.The returned device was inspected and the scope¿s nozzle was replaced.In addition, as part of our investigation, the olympus field service engineer (fse) has advised that the foreign matter can be removed.The fse identified the foreign matter in the nozzle as the debris of the rubber from the perfusion cannula.The fse reported that the customer can reprocess the scope/nozzle in accordance with the reprocessing manual and advised the customer to pay attention to the loss of full perfusion and replace it in time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received 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.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, it is likely that a part of the perfusion cannula was broken, a broken piece entered into the air/water channel, and then the nozzle was clogged with it.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "-operation manual_ preparation and inspection of the endoscope_ inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.-inspection of the endoscopic system.* inspection of the air-feeding function.* inspection of the objective lens cleaning function." olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13165320
• MDR Text Key: 286731770
• Report Number: 8010047-2022-00872
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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-Q260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2012
• 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: GIF-Q290 (SERIAL # UNK)