MAUDE Adverse Event Report: OLYMPUS AMERICA, INC SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/18/2022

Event Type  Injury  

Event Description

The customer reported to olympus that during a polypectomy surgical procedure, the single use repositionable clips did not reopen after grabbing the tissue which caused more bleeding.There was a report of a an approximately 15 minutes.There was no blood transfusion or fluids given due to the bleeding.The case was completed with competitor clips.This complaint requires 3 reports: the related reports are as follows: (b)(6)-device # 1 of 3.(b)(6)-device# 2 of 3.(b)(6)-device # 3 of 3.This medwatch reports is for: (b)(6)-device # 3 of 3.

Event Description

Olympus further received information that the user had to rip the clip off of the tissue because it was not disconnecting from the catheter.The clips did not remain in the patient.No additional interventions done.The patient was not hospitalized or had their period of hospitalization extended.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16519409
• MDR Text Key: 311045448
• Report Number: 2429304-2023-00039
• 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: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2022,03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• 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: 24K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention