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

Model Number NM-401L-0623

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for investigation.The exact cause could not be conclusively determined.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.A supplemental report will be submitted, if additional and significant information becomes available at a later time.Cross reference mfr.Report number: 8010047-2016-00388, 8010047-2016-00389.

Event Description

Three subject devices were used for treatment of the varix.The subject devices had no malfunction before using them.The doctor attempted to inject the adrenalin, but the adrenalin could not be come out.He attempted to retract the needle tube in the tube sheath for the exchange of the device.But the needle tube could not be retracted.Three of them had the similar malfunction.As a result, the doctor could not stop bleeding.It was unknown whether the procedure was completed or not.However, as a result of additional investigations, olympus medical systems corp.(omsc) found that no patient's serious injury was reported.In addition, the doctor commented that he could not inject the adrenalin due to kinking of the subject device.This is the third of the three reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the evaluation of the returned device.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.The cause of this event couldn't be determined conclusively.However, based on the evaluation of mfr.#8010047-2016-00388, the retraction failure couldn't be ruled out as a contributory factor to the reported event.Cross reference mfr.Report number: 8010047-2016-00388, 8010047-2016-00389.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5506848
• MDR Text Key: 40534085
• Report Number: 8010047-2016-00390
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K914496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0623
• Device Lot Number: 58K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1