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

Model Number	HX-20U-1
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 8010047-2021-04413
• Device Sequence Number: 14330333
• Product Code: FHN
• UDI-Device Identifier: 04953170044922
• UDI-Public: 04953170044922
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 04/06/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/01/2021; 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR