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

Model Number HX-400U-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The evaluation confirmed the reported "the device's handle wire broke and fell off".A visual inspection was performed on the received condition and noted that the ligating device was damaged.The handle was inspected and noted the wire was broken located between the slider.The broken wire was bent and coming out of the handle area.The insertion portion was checked and a dent was observed on the base of the yellow tube joint.Additionally, the distal tip was damaged; the blue loop was broken with evidence of foreign material.Based on the evaluation results, the reported broken wire at the handle was potentially attributed to excessive force.As a preventive measure, the instruction manual provides warnings and cautions to prevent patient injury and device damage which states: before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, punctures, hemorrhages or mucous membrane damage and may result in more severe equipment damage.Always have a spare instrument available.

Event Description

The manufacturer was informed that during a procedure, the device's handle wire broke and fell off into the patient.The broken wire was removed from the patient using a second scope during the same procedure, there was no patient injury reported.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9137841
• MDR Text Key: 214608560
• Report Number: 8010047-2019-03432
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 7XV 25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1