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

Model Number GIF-H260

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

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

The customer reported to olympus during reprocessing before use, air and water could not pass through the device smoothly.There was a delay to the procedure of no more than 15 minutes.The facility confirmed cleaning was performed with the mh-946 injection tube and a non-olympus automatic endoscope reprocessor.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The evaluation confirmed the reported issue.According to the inspection results by repair center engineer, the nozzle was clogged by foreign material, but the foreign material could not be identified.After the nozzle was removed, air and water feeding returned to normal.Additionally, the angulation was insufficient, there was great angle play, the internal elements in the bending section were misaligned, the insertion section was wrinkled slightly.And the root of the insertion section was buckled, causing two circle folds.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.The device met all specifications at the time of shipment.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely that a piece of the injection tube or the silicone rubber entered in the channel and clogged the nozzle.The specific root cause could not be determined at this time.The user may detect the suggested event by handling the device in accordance with the instructions for use: "preparation and inspection.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 field performance for 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: 14014151
• MDR Text Key: 298304729
• Report Number: 8010047-2022-05676
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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-H260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• 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: UNKNOWN 290 DEVICE.