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

Model Number GIF-H180

Device Problems Partial Blockage (1065); Residue After Decontamination (2325)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated at rrc (regional repair center) olympus (b)(4).Device return evaluation noted initial leakage and electrical safety tests were performed reporting distal end insulation test failure.Technical investigation was performed reporting the listed faults: channel mount unit found clogged when trying to brush passage test and forceps passage test, foreign material found at the channel mount unit.Angle wires found with play (adjustment required), c-cover found scratched and dented, universal cord with coat peeling off.Connecting tube slightly scratched.Lg (light guide) cover glass scratched.El connector discolored.Suction cylinder discolored.S-cover scratched.Grip scratched.Several traces of mechanical damage were found.Service repair noted customer fault description were confirmed and likely to be a result of incorrect handling of the device.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, the device channel mount unit clogged.Foreign body stuck in the canal.The issue found during device testing.There is no patient impact or harm associated on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.The following sections were corrected: g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, customer and technician reported issue was confirmed and likely to be a result of incorrect handling of the device.From the shape, the foreign material is thought to be a piece of endotherapy accessories.The following are possibilities: the user aspirated a clip by mistake during procedure and the clip got stuck in the biopsy channel.The clip got stuck in the biopsy channel including the channel mount unit because its jaw opened and the clip was not discharged by correct brushing.Device handling differed from ifu.The instruction manual identifies the following related verbiage: ¿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.After discharging, confirm that there is no irregularity in the suction function according to ¿inspection of the suction function¿ on page 50, before using the endoscope again.If the thick fluid or solid matter cannot be discharged, stop using the suction function and contact olympus.¿ type of clip is not specified.Ifu of olympus clip (hx series etc.) says that the clip could be stuck within the biopsy channel if the user suctioned it with endoscope.Ifu also says about measures for the aspirated clip.¿chapter 3 preparation, inspection and operation clipping tissue: when aspirating body fluid via the endoscope, be careful not to aspirate a clip or clip connector which has been dropped inside the body cavity, as this could clog up the suction channel or cause the clip/clip connector to be stuck in the suction valve and disable the endoscope¿s suction function.If a clip or clip connector is accidentally aspirated into the endoscope, follow the procedure given in ¿removal of an aspirated clip or clip connector¿ on page 41.¿ the user can prevent the suggested event and detect clip in the biopsy channel prior to use for the following ifu statement: ¿inspection of the endoscopic system: inspection of the instrument channel: 1 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.2 confirm that the endo therapy accessory can be withdrawn smoothly from the biopsy valve.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 12888100
• MDR Text Key: 283694686
• Report Number: 8010047-2021-15211
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170202285
• UDI-Public: 04953170202285
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K100584
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2012
• 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