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

Model Number	HX-202UR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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).
Event or Problem Description
This supplemental report is being submitted to include additional information received.The following sections have been updated: b2, b5, f6, f10.The patient was transferred to the hospital for observation due to the blood loss and required another procedure to stop the bleeding.

• 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
• MDR Report Key: 18213628
• Report Number: 2429304-2023-00363
• Device Sequence Number: 5709514
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024
• Report Date (Section F): 10/30/2023

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?: No
• 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?: Yes
• Distributor Facility Aware Date: 12/18/2023
• Device Age: 3 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown