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

Model Number HX-202UR

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  Injury  

Event 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
• Type of Device: 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: 16525636
• MDR Text Key: 311098469
• Report Number: 2429304-2023-00043
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2023,03/10/2023

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
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 27K 15
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SINGLE USE REPOSITIONABLE CLIP - LOT 27K 15.; SINGLE USE REPOSITIONABLE CLIP - LOT 27K 20.
• Patient Outcome(s): Required Intervention