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

Model Number	HX-202UR
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus representative reported on behalf of the customer that three single use repositionable clips failed to deploy properly during a colonoscopy with polypectomy while the patient was bleeding causing the procedure to extend by 20-30 minutes, and eventually, cancelled.The patient was transported to a local hospital to stop the bleeding and the patient subsequently underwent another colonoscopy using third-party clips.The three clips were left inside the patient and will not be returned.There was no further medical intervention needed and no further patient impact reported.This event is reported under the following related patient identifiers: (b)(6) - single use repositionable clip 1/3.(b)(6) - single use repositionable clip 2/3.(b)(6) - single use repositionable clip 3/3.This medwatch is for patient identifier (b)(6).

• 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: 17670191
• Report Number: 2429304-2023-00280
• Device Sequence Number: 7068383
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/01/2023
• Report Date (Section F): 08/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 22K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown