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

Model Number	HX-202UR
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that while using a single use repositionable clip during a colonoscopy with polypectomy, the clip would seal and fire but would not stay closed once deployed after the surgeon pulled it from the mucosa.The clip did fall into the patient, and was retrieved.A different device and four clips were used to complete the procedure.The procedure was delayed while the circulating nurse retrieved another device.There was no patient injury.Three clips in total were returned but it was unknown if all three were used in the procedure.Additional information was requested multiple times without response.Patient identifier (b)(6) is for clip with lot number 27k 20.Patient identifier (b)(6) is for clip with lot number 27k 15.Patient identifier (b)(6) is for clip with lot number 275 15.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: LIGATION CLIP, METALLIC
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 16525255
• Report Number: 2429304-2023-00041
• Device Sequence Number: 5246113
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2023
• Report Date (Section F): 02/10/2023

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: 27K 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2023
• 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: SINGLE USE REPOSITIONABLE CLIP - LOT 27K 15.; SINGLE USE REPOSITIONABLE CLIP - LOT 27K 15.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown