MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Positioning Failure (1158)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/06/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports a patient presented to the emergency room vomiting blood.The patient was referred for emergency endoscopy.The patient he had an ulcer in the antrum of the stomach, which was hemorrhaging, it was bleeding a lot.The physician wanted to install clips to stop the bleeding.According to the nurse's count, 5 clips did not work out of the 9 clips used.The patient was on a massive infusion protocol (ptm) to compensate for his state of hemorrhage.The failure of the clips to work greatly complicated the procedure and could have been very serious for the patient.The clips did not close on the mucosa.Thirty-six hours later, the patient had a lower hemoglobin level.The doctor went back to see the ulcer and the four clips that had been installed had already fallen off.The physician cauterized the ulcer with a tie to stop the bleeding that was still active.The patient is stable, and his condition is improving.It is possible that the remaining 4 clips may not have worked as intended either.The time prolongation of the procedure increased the patient¿s risk related to the hemorrhage.Case with patient identifier: (b)(6) reports clip 1 of 9 that failed, case with patient identifier: (b)(6) reports clip 2 of 9 that failed, case with patient identifier: (b)(6) reports clip 3 of 9 that failed, case with patient identifier: (b)(6) reports clip 4 of 9 that failed, case with patient identifier: (b)(6) reports clip 5 of 9 that failed, case with patient identifier: (b)(6) reports clip 6 of 9 that failed, case with patient identifier: (b)(6) reports clip 7 of 9 that failed, case with patient identifier: (b)(6) reports clip 8 of 9 that failed, case with patient identifier: (b)(6) reports clip 9 of 9 that failed.

Event Description

The following additional was received from the customer: it was reported that the clips were used to grasp ¿regular tissue,¿ not stiff tissue, and were installed by being pressed on the patient mucosa.The clips did not open or close.When the user attempted to close the first time, the clip fell and there was ¿no strength on the closing.¿ it was confirmed that the clips were not deformed.The facility has been using this type of clip for at least three years, and they report being familiar with using this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The facility discarded the device and it was not returned for inspection.However, olympus conducted testing using a hx-202ur (lot.25k14), and after grasping silicone rubber simulating tissue and releasing the clip, the distance outside the clip is measured.Testing confirmed the clip's gripping force was within the specified value.The subject device was manufactured in may 2022, but the specific date is unknown.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 investigation, there was no problem with the manufacturing records and the amount of gripping force of the clips.Therefore, the cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿re-bleeding may occur on the clipping site depending on the local condition or the grasping condition.Check the patient for any re-bleeding after the operation as appropriate.¿ ¿do not force the distal end of the insertion portion on the clip against body cavity tissue.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿do not force the clip against body cavity tissue.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.The clip may be deformed and therefore does not close properly.This could result in reduced performance.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL CLIP
• 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: 15935500
• MDR Text Key: 305047944
• Report Number: 9614641-2022-00729
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 14953170385947
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 25K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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; Required Intervention