MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LIGATING DEVICE

Model Number HX-20U-1

Device Problems Entrapment of Device (1212); Failure to Cut (2587); Ejection Problem (4009)

Patient Problem Tissue Damage (2104)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

The hx-20u-1 ligating device has not been returned to the service center for evaluation for "not releasing and getting stuck in a polyp".Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a report of a ligating device, reusable loop, (hx-20u-1), lot number 98k, that would not release from a polyp and had to be surgically retrieved.The physician was performing a polypectomy and used two loops to cut a polyp when one loop became stuck in a large polyp.It was reported the loop device would not release from the accessory, and the physician had to perform surgery to retrieve the polyp with the loop.It was not reported the length of time the patient was under general anesthesia but it was reported there was no blood loss.It was reported the surgery was successful and the patient was stable.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).Please see updated sections: d10, g4, g7, h2, h3, h6 and h10.The device was not returned to the service center for evaluation, therefore we are unable to provide the root cause of the reported event.The original equipment manufacturer (oem) performed a device history record (dhr) review for the finished product and no deviations or non-conformances were noted in the documentation or the processes.

• Brand Name: LIGATING DEVICE
• Type of Device: LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9742916
• MDR Text Key: 202942981
• Report Number: 8010047-2020-01479
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170044922
• UDI-Public: 04953170044922
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-20U-1
• Device Lot Number: 98K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1