MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number HX-201UR-135

Device Problems Break (1069); Unintended System Motion (1430); Detachment of Device or Device Component (2907)

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

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A customer reported to olympus, single use rotatable clip fixing device had insufficient opening of the clip and early closure, making its use unfeasible.Although the device is characterized as rotatable, the command obeys slowly and would end up rotating more than necessary, delaying the procedure, which in case of hemorrhages, could be dramatic.There was no report of patient harm associated with this event.

Event Description

The customer reported that the issue occurred during an unspecified therapeutic procedure.The procedure, and in turn, the patient's anesthesia, were extended for an unknown duration due to the need to use another device to solve the issue.The customer also noted that there was "breakage and/or fall of any fragment in any cavity of the patient" during the use of the device, which was observed at the initial point of the procedure.There were no reports of any unexpected bleeding during the procedure and no need for longer hospitalization or surgery due to availability of other types of endoclips with more efficient functioning as well as other techniques endoscopists use to avoid this outcome.The customer indicated that the procedure was not completed.However, an olympus representative reported that the procedure had to be completed with another device.There was no further patient impact reported.An olympus product specialist also commented that the customer was not used to this product and did not request training.Consequently, the physician has been contacted for training.Additional information has been requested clarifying the event details; however, no further information has been received at this time.

Manufacturer Narrative

The suspect device referenced in this report will reportedly not be sent to the repair center as it is not repairable.The device was manufactured in january 2021 based on the provided lot information "11k".The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or upon receipt of additional information.

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.Although the specific day is unknown, the device was manufactured in january 2021.Based on the results of the investigation, since the device was not returned for evaluation, the reported issue could not be identified.Therefore, the root cause could not be determined.However, it is likely that the clip closed due to the slider being pulled during the preparation for use or while being inserted into the endoscope.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿this instruction manual contains essential information on using this instrument safely and effectively.Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed.If you have any questions or comments about any information in this manual, please contact olympus.¿ ¿do not move the slider when extending the clip from the tube sheath.Otherwise, excessive force will be exerted on the clip and the clip will be closed or detached from the instrument.¿ this supplemental report includes a correction to d8 and d9 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Type of Device: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17981123
• MDR Text Key: 326317373
• Report Number: 9614641-2023-01569
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170193026
• UDI-Public: 04953170193026
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-201UR-135
• Device Lot Number: 11K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other