MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number TJF-Q190V

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, during an ercp, the surgeon attempted to place a clip and it would not deploy to a bleeding polyp after it was snared.The surgeon attempted to remove the clip and it may have gotten stuck inside the endoscope channel.It is unknown if the clip was in the channel or fell into the patient.The customer reported a delay of 'a few minutes.' the endoscope was returned for evaluation and no clip was identified in the endoscope.This event includes 2 reports: (b)(6) is for tjf-q190v.(b)(6) is for unknown olympus clip.This report is 1 of 2 for (b)(6) is for tjf-q190v.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.The olympus service center evaluated the device and identified the following: channel kinked, scratches and dent on hold ring, distal sheath adhesive cracked, insertion tube has scratches, minor scratches and dent on plug unit gold pin.The clips was not found inside the endoscope channel.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer and the device evaluation results.The olympus service center evaluated the device and did not identify any foreign material inside the channel.The scope had tear marks, the channel was kinked, scratches and dent on hold ring, bending section cover glue has crack, insertion tube with scratches and plug unit/gold pin with minor scratches and dent.

Event Description

Additional information received from the customer: the olympus clip would not release from the cable when deploying it to a snared bleeding polyp.The customer pulled the clip snuggly off of the tissue and pulled the already closed nondeployed clip back into the biopsy channel.When pulling the clip out of the scope through the biopsy channel there was no clip on the distal end.So either the clip got dislodged in the scope or it fell off before.The customer reported the team did not see it fall off nor did we view it in the colon as we looked thoroughly to find it.A similar scope was used to complete the procedure.No pictures available for the clip.All channels were brushed by the customer numerous times but the clip was not lodged inside the channels, nothing came out.The channels were also visually inspected with a magnifier and nothing was identified.Therefore, the scope was returned for your evaluation.If the clip was not identified in the scope then it likely fell off inside the patient.The customer stated if the clip fell off in the colon, as clips in general will fall of after so many weeks, are exited via stool.There was a surgical delay of a few minutes.The customer reported they will be following up with the patient due to an already previously scheduled procedure due to polyps found in the colon.This report (b)(6), is for tjf-q190v, 2023436.(b)(6) is for hx-202ur quick clip pro.

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 almost 2 years since the subject device was manufactured.Based on the results of the investigation, the clip likely detached from the coil sheath by contacting the inner wall of the biopsy channel while the user was pulling out the hx-202ur through the device.Thus, causing the clip to fall into the patient¿s body.However, the root cause could not be determined.Furthermore, the following factors likely contributed to the event: 1.The user used the subject device that has forceps elevator in combination with the hx-202ur, which was a deviation from the instructions for use (ifu).As a result, the clip was not properly deployed.2.The user did not handle the device in accordance with measures in case and the clip could not be detached from coil sheath, which is described in ifu for hx-202ur.The event can be detected/prevented by following the ifu which state: ¿specifications: do not use this instrument with an endoscope equipped with a forceps elevator.When using the instrument with a two-channel endoscope, never insert this instrument into the channel with a forceps elevator.Raising the forceps elevator may weight down the slider causing the clip to malfunction and/or making it difficult to detach the clip from the instrument.¿ ¿moreover, countermeasures in case clip cannot be detached from coil sheath is described in the following item in ifu.However, since there was a difference between what the user performed and the countermeasures, the user handling of the device may have been deviated from ifu.¿ ¿emergency treatment: withdrawing the instrument from the endoscope if the clip cannot be detached.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15475482
• MDR Text Key: 304994068
• Report Number: 9610595-2022-02170
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• 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: HX-202UR QUICK CLIP PRO, UNKNOWN LOT.; UNKNOWN OLYMPUS CLIP.