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

Model Number GIF-H190

Device Problems Residue After Decontamination (2325); Failure to Clean Adequately (4048)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, "something came out of the scope while it was in the patient.Customer stated no one could verify as the user did not show what came out from the scope.Customer stated ," they are not sure about the insertion tube, it might need to be repaired or replaced".The issue found during an unspecified procedure.There was no patient harm or injury reported due to the event.No user injury was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.Customer stated that the follow up question will be forwarded to their director.No further information provided.Investigation ongoing.This report will be supplemented accordingly following completion of 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, it is likely that because of inappropriate reprocessing after the previous procedure, foreign materials entered into the air/water channel, and then the materials were pushed by water or air during procedure.A definitive root cause cannot be identified.Users can detect the suggested event properly by handling the device in accordance with the following instructions for use (ifu)."·inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.·inspection of the endoscopic system, - inspection of the air-feeding function, - inspection of the objective lens cleaning function.·inspection of ancillary equipment - inspect the following equipment as described in their respective instruction manuals." users can decrease/prevent the suggested event by handling the device in accordance with the following ifu."·an insufficiently reprocessed endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.If the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.·to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the aw channel cleaning adapter (mh-948) after each patient procedure.·troubleshooting - the accessories are consumables.Olympus does not repair accessory parts.If an accessory part becomes damaged, contact olympus to purchase a replacement" olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates and to inform that this report is related to a report with patient identifier (b)(6).Communication and response from the customer (nurse director of surgery), the following information conveyed: foreign material fell off inside patient at start of procedure and was removed immediately by suction.Each procedure was completed.The provider was asked if he wanted the scope replaced to which he replied no.Olympus will continue to monitor complaints for this device.

• Brand Name: EVIS EXERA III 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: 13173374
• MDR Text Key: 287321692
• Report Number: 8010047-2022-00954
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2012
• 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