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

Model Number	HX-202UR
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that during an unknown procedure using this single use repositionable clip, the clip did not reopen after grabbing the tissue and caused more gastrointestinal bleeding.The only way to remove it, as reported was to rip it off.The bleeding was stopped using a competitor clip.The procedure was delayed for fifteen (15) minutes.No additional intervention was done other than more hemostasis that was needed.There were no reports of further patient or user harm associated with this event.
Event or Problem Description
Olympus further received information that the device was used for colonoscopy hemostasis.The device was deployed in colon or upper gastrointestinal tract.The patient was not hospitalized or hospitalization was not extended due to the reported event.

• 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: 16479828
• Report Number: 2429304-2023-00029
• Device Sequence Number: 11550956
• Product Code: PKL
• UDI-Device Identifier: 04953170345180
• UDI-Public: 04953170345180
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023
• Report Date (Section F): 11/18/2022

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: 25K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2022
• 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: 03/03/2023
• Supplement Report FDA Received Date: 03/31/2023
• 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: Required Intervention
• Patient Sex: Unknown