MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE INJECTOR NM; INJECTOR AND SHEATHSET

Model Number NM-201L-0625

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) 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 a varicose endoscopic treatment, the subject device was used.The user could not retract and extend the needle into/out the sheath quickly and easily.There was a bleeding after retracted or extended the needle.No further information was provided.This is the report regarding the bleeding.

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 and it was not concluded the subject device would be contribute to the reported bleeding.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Based on the similar cases in the past, it is most likely the reported phenomenon was caused by following factors; -increased frictional resistance between the outer tube and the needle tube, which was probably induced by the kinks on the outer tube.-the insertion portion of the endoscope was excessively bent or the endoscope was angulated too much.The above device handling has warned in the instruction manual as follows.*when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.*insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.

Manufacturer Narrative

This is a supplemental report to provide additional information.On july 5th, 2019, olympus medical systems corp.(omsc) received additional information regarding event description.Described in b5.

Event Description

The intended procedure was completed with another device.There was no patient injury reported excluding the bleeding.

• Brand Name: DISPOSABLE INJECTOR NM
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8720520
• MDR Text Key: 149165410
• Report Number: 8010047-2019-02247
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-201L-0625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1