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

Model Number	NM-401L-0523
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle could not be extended from the outer tube.Injection could not be performed while the slider was pushed, but injection could be performed while the slider was pulled.The outer tube was buckled at 280 mm, 395 mm and 560mm from the distal end.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 the frictional resistance between the outer tube and the needle tube increased due to the bending of the tube or pushing the slider fast, and then the needle tube was compressive buckled when the needle was extended and injection could not be performed.The above device handling has warned in the instruction manual as follows.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Operate the slider slowly, otherwise the tube could buckle.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.Stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.
Event or Problem Description
During an unspecified procedure, the subject device was used.The needle could not be extended.The intended procedure was completed with another device.There was no patient injury reported.On july 3, 2020, olympus medical systems corp.(omsc) found that the subject device could not perform the injection.This is the report regarding the failure of injection.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: 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: 10294120
• Report Number: 8010047-2020-04586
• Device Sequence Number: 16800331
• Product Code: FBK
• UDI-Device Identifier: 04953170382352
• UDI-Public: 04953170382352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: NM-401L-0523
• Device Lot Number: K9X23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1