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

Model Number NM-401L-0423

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

During a mucosectomy, the needle of the subject device used for the injection of nacl could not be retracted into the tube.The procedure was completed with a similar device.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2017-00846 to provide additional information based on the evaluation of the device.Lot # was corrected.The subject device was returned to olympus medical systems corp.(omsc).Omsc investigated it on september 11, 2017.The needle of the subject device remained to be retracted into the sheath.The needle could not be extended from the sheath.The sheath and the needle tube were kinked at about 55 mm and 110 mm from the distal end of the sheath.The needle tube was compressive buckled.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that excessive load was applied to the sheath and the needle tube when the subject device was inserted into the endoscope, taken out from the sterile package, or checked before use, and then the sheath and the needle tube were kinked.Due to the kinks, friction resistance between the sheath and the needle tube became large, and the needle could not be retracted into the sheath.Because friction resistance between the sheath and the needle tube was large, the compressive buckling occurred when the needle was extended from the sheath.The instruction manual of the device has already warned as follows; warnings: operate the slider slowly, otherwise the tube could buckle.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6699846
• MDR Text Key: 79905979
• Report Number: 8010047-2017-00846
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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: Health Professional
• Device Model Number: NM-401L-0423
• Device Lot Number: K6901
• Other Device ID Number: 04953170382338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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