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

Model Number HX-202UR

Device Problem Failure to Eject (4010)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 02/22/2023

Event Type  Injury  

Event 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
• 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
• MDR Report Key: 17670191
• MDR Text Key: 322494790
• Report Number: 2429304-2023-00280
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/22/2023,09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention