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

Model Number	HX-202UR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Eject (4010)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus representative reported on behalf of the customer that the two single use repositionable clips could not be deployed during the diagnostic esophagogastroduodenoscopy (egd) procedure as the clear sheath was broken at the proximal end.The procedure was prolonged by 15 minutes and resulted in more blood loss than necessary as a result of the issue.The procedure was completed with a third clip and the patient was then transferred for observation due to the blood loss.Related patient identifier: (b)(6) single use repositionable clip (hx-202ur / 37k).
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304-2023-00362.
Additional Manufacturer Narrative
This supplemental report is being submitted to include additional information received.The following sections have been updated: b2, b5, h6.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304 - 2023 - 00362.
Event or Problem Description
The patient was transferred to the hospital for observation due to the blood loss and did require another procedure to stop the bleeding.
Additional 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 less than 1 year since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the reported issue could not be confirmed.However, it is likely that the sheath was damaged during handling of the device; therefore, the clip was unable to be removed from the sheath.This issue may have caused or contributed to the patient adverse event (blood loss requiring additional interventions).Although, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope, instrument, and/or clip.¿ ¿when inserting the instrument into the endoscope, do not pull the slider forcibly.Otherwise, the clip may not open.¿ ¿operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip cannot be detached from the instrument or if any other unexpected circumstance takes place.In this case, refer to chapter 14, ¿emergency treatment¿.¿ ¿do not withdraw the instrument forcibly or change the angulation of the endoscope when the clip is grasping the tissue and is not released.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿do not angulate the bending section of the endoscope or withdraw the instrument from the endoscope while the clip is grasping the tissue before being released.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding, or mucous membrane damage.¿ ¿should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of ¿withdrawing the instrument from the endoscope¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result.¿ this supplemental report includes an update to b2 and h6 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: 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: 18213577
• Report Number: 9614641-2023-01781
• Device Sequence Number: 20513575
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 37K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 02/16/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/11/2024; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHEATH.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown