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

Model Number HX-20U-1

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that after placing the ligating device's endoloop (for removal of the polyp) during a procedure, the loop did not release.The loop was stuck inside the applicator.This was the second use of this product.The user that handled the device had familiarity with all the particularities of the product.No patient injury or infection reported.

Event Description

The user facility reported to olympus that after placing the ligating device's endoloop (for removal of the polyp) during a procedure, the loop did not release.The loop was stuck inside the applicator.There was a surgical delay of two (2) hours while the patient was under general anesthesia.This was the second use of this product.The user that handled the device had familiarity with all the particularities of the product.No patient injury or infection reported.

Manufacturer Narrative

This supplemental report is submitted to provide a correction.The initial aware date of event was (b)(6) 2021 and not (b)(6) 2021.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 11596436
• MDR Text Key: 243342197
• Report Number: 8010047-2021-04413
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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: 9YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR