MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LOOP

Model Number	MAJ-340
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An unused loop (maj-340) was returned together with the ligating device to olympus medical systems corp.(omsc).The insertion portion of the ligating device was severed.No other abnormalities were observed about the ligating device.The subject device was not returned to omsc for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc assumes that this event occurred since the loop was caught between the hook and the coil sheath after the loop was released in the tube sheath for unspecified reason.The above device handling has warned in the instruction manual of the ligating device as follows: do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.
Event or Problem Description
We received the following report.During a procedure, the subject device was used to ligate polyp.After ligating the polyp, the loop of the subject device could not be released since the loop was pulled into the coil sheath and the user could not operate the handle any more.The user used loop cutter to cut the loop.The user withdrew the subject device from the patient.There was no patient injury reported.No further information was provided.This is the report regarding the failure of releasing the loop.

• Brand Name: LOOP
• Common Device Name: LOOP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9657876
• Report Number: 8010047-2020-01068
• Device Sequence Number: 687933
• Product Code: MND
• UDI-Device Identifier: 04953170045028
• UDI-Public: 04953170045028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: No Information
• Device Model Number: MAJ-340
• Device Lot Number: 93K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1