MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2023

Event Type  Injury  

Manufacturer Narrative

Reporter address - (b)(6).Foreign matter related questionnaire found that the customer cleaned disinfected and sterilized the device before it was sent to olympus.There was no time lag between the end of clinical use and the start of pre cleaning.The customer aspirated the water through the instrument/suction channel.The customer wiped brushed the instrument channel outlet with clean lint free cloths, sponges or brushes.There were no abnormalities and accessories used for reprocessing.The customer brushed the instrument channel instrument channel port and suction cylinder.The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus employee reported on behalf of the customer that clip was removed from the forceps channel with the intention of using it in a case but it was unused.When the clip body was removed from the scope, the clip and the connecting rod were not attached so it was assumed that they remained inside the forceps channel.The physician did not inform the cleaning staff that the clip was missing and neither of them were found during cleaning in the olympus endoscope reprocessor.During the next diagnostic colonoscopic procedure the missing connecting rod became dislodged in the patient's intestine and was not recovered.The procedure was completed with the same device with no procedural interruptions or extensions.The missing clip could not be found.No health hazards reported.Additional follow-up has been conducted for clarification on the procedure and the patient outcome; however, no information has been received at the this time of the report.The event has been reported under the following patient identifiers involving the following devices: 1) patient identifier # (b)(6), evis lucera elite colonovideoscope; model #pcf-h290zi, sn (b)(6).2) patient identifier # (b)(6), long clip; model # hx-610-090l, sn- unknown.3) patient identifier # (b)(6), endoscope reprocessor; model # oer-4, sn- unknown (this rport).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the reported event was likely caused by the user¿s handling of the device.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿section 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 is 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,¿ before using the endoscope again.If the thick fluid or solid matter cannot be discharged, stop using the suction function and contact olympus.¿ this supplemental report includes additional information added to d4 (device serial number).Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.This supplemental report also includes information added to h4 and h6.

Event Description

It is unknown if the clip is still in the patient.Even if the clip were to fall off, there are no plans to retrieve it.The reason is that the clip does not click when using the clip.The customer doesn¿t take the trouble to collect the clip because the reason for this is that the clip is not collected even when it is used, and it is believed that the clip is ejected naturally with the stool, so we have heard that the customer does not bother to collect it.Unknown if the patient had preexisting conditions.The patient has not been hospitalized for testing, required additional hospitalization, or developed complications due to the reported event.

Manufacturer Narrative

This report is being supplemented to provide a correction with information inadvertently left out.Updated field (b5).

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17908988
• MDR Text Key: 325338288
• Report Number: 9610595-2023-14919
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 10/27/2023; 10/30/2023
• Supplement Dates FDA Received: 10/19/2023; 10/27/2023; 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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: COLONOVIDEOSCOPE- PCF-H290ZI, SN (B)(6); LONG CLIP HX-610-090L SN-UNKNOWN.; ROTATABLE CLIP FIXING DEVICE, HX-110QR, SN- UNK.
• Patient Outcome(s): Other
• Patient Sex: Female