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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a polypectomy of a large pedunculated polyp in the sigmoid, the subject device was used.The loop was closed and could not be detached as the wires were bent in the handle.The user cut wires and loosened the loop with help of diathermy.The intended procedure was completed with large clips.The sedation and duration of the examination was extended from 30 minutes to 110 minutes.The patient had massively prolonged intravenous anaesthesia with drop in blood pressure and circulatory problems.It was reported circulatory support was needed.There was thermal damage to the intestinal wall due to needle knife with diathermy.

Manufacturer Narrative

This is a supplemental report to provide additional information.It was additionally reported that the examination time was extended to approximately 1 hour, but the patient's health and circulation were stable and the intended procedure was completed.The patient had no late effects.As a result, omsc concluded that the reported event was not reportable event.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE 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: 10964026
• MDR Text Key: 220240488
• Report Number: 8010047-2020-09992
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HX-400U-30
• Device Lot Number: 02V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention