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

Model Number GIF-1TH190

Device Problems Device Reprocessing Problem (1091); Device Damaged by Another Device (2915)

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

Event Date 08/20/2021

Event Type  malfunction  

Event Description

It was reported by the customer, there was a possible piece of suture inside the evis exera iii gastrointestinal videoscope, had to pry off suction button.Upon follow-up with the customer, the issue was clarified; while cleaning the evis exera iii gastrointestinal videoscope, a piece of suture came out of the scope.It was unknown if it was a clip or thread.No patient harm reported.During the evaluation of the device, it was noted parts such as the forceps valve and/or endoscopy accessories fell on the suction channel and the scope was insufficiently or incorrectly reprocessed.This report is to capture the reportable malfunction of forceps valve and/or endoscopy accessories fell on the suction channel and the scope was insufficiently or incorrectly reprocessed noted at estimation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the issue was confirmed.Deep scratches were found inside the biopsy channel.However, the brush passage had no restrictions.Switch one (1) had a leak.The bending section cover glue was cracked and the insertion tube had excessive buckles.The labeling was peeling and had scratches.The image had one (1) white dot.The angulation was low, and the control knob movement right/left was loose.The distal end plastic cover had deep dents.And the scope connector had deep dents at the plug unit.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 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the error is due to improper use of endo therapy accessories, improper suction operation or insufficient reprocessing.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): ifu (reprocessing manual) specifies about inspection of the biopsy channel as below: ¿3.8 inspection of the endoscopic system inspection of the instrument channel insert the endo therapy accessory through the biopsy valve.Confirm that the endo therapy accessory extends smoothly from the distal end.Also, make sure that no foreign objects come out of the distal end.¿ - ifu (operation manual) specifies about suction of solid matter as below: ¿4.2 insertion suction: warning: if the suction valve clogs and the suction cannot be used when solid matter, such as the clip or thick fluid, are aspirated, withdraw the endoscope and disconnect the suction tube from the suction connector on the endoscope connector.Attach a syringe containing sterile water to the suction connector.Straighten the insertion tube as much as possible and forcefully flush the connector with the water while the suction valve of the endoscope is slightly depressed.Repeat the flush until the thick fluid or solid matter are discharged from the distal end of the suction channel.¿ - ifu (reprocessing manual) says to reprocess all channels as below: ¿1.4 precautions: warning: all channels of the endoscope, including the instrument channel and the auxiliary water channel, and all accessories used with the endoscope during the patient procedure, such as all valves and the auxiliary water tube (maj-855), must be reprocessed after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators.¿ olympus will continue to monitor the field performance of 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: 12599288
• MDR Text Key: 281346286
• Report Number: 8010047-2021-12924
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• 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