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

Model Number HX-400U-30

Device Problem Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned to the service center for evaluation.The exact cause of the reported event cannot be determined.However, based on similar cases the original equipment manufacturer (oem) provided the following most likely causes: when the user strongly pulled the slider, the polyp was forcibly ligated.Then the polyp was cut.The user pulled the slider of the subject device further than intended and the loop stopper came off from the loop.The loop could not be closed since the loop stopper was missing.The instruction manual warns users ¿do not apply unnecessary force to the loop when ligating tissue during the procedure.Excessive force applied to the loop could cut the surrounding body cavity tissue, resulting in patient injury, such as hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument.If additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

The user facility was informed that during an unspecified procedure, the first loop broke while opening the package.A second loop was opened and used.After placing the loop around the patient¿s polyp, the loop cut through the polyp prematurely.There was minor bleeding observed that was treated with cautery.The intended procedure was completed.There was no patient injury reported.In addition, on june 7, 2019 the service center received medwatch report # (mw5086887) that corresponds with the reported 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8692913
• MDR Text Key: 147872344
• Report Number: 2951238-2019-00934
• 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: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: HX-400U-30
• Device Lot Number: 6YV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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