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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an unspecified procedure, the subject device was used.The loop of the subject device could not be released, and the handle broke.The user severed the insertion portion of the subject device.The user withdrew the endoscope from the patient while leaving the subject device inside the patient.The user inserted the endoscope into the patient again and cut off 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.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(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, it was known 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 as follows.Do not try to forcibly withdraw the instrument from the endoscope when the loop cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as punctures, hemorrhages or mucous membrane damage.If the loop cannot be detached from the instrument, follow the procedures described in this section.If there are any deviations or crushed sections on the distal end of the coil sheath, it may not be possible to detach the loop from the instrument.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.

• 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
• MDR Report Key: 9657037
• MDR Text Key: 221019550
• Report Number: 8010047-2020-01058
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

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
• Device Operator: No Information
• Device Model Number: HX-400U-30
• Device Lot Number: 96V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/02/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1