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

Model Number	NM-401L-0425
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
We received the following report.*the subject device was used for botox injection into the bladder.The customer couldn't inject as there was too much resistance.The customer tested another one outside of the bladder lining and still wouldn't work.The customer paused the procedure.After that, the customer managed to complete the intended procedure while extending the needle from the tube (without retracting it back into the tube) since the customer found that once extended the needle from the tube, could not retract it into the tube.There was no patient injury reported.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.Four devices were returned for investigation.This is the report on the first one of the four devices.The needle could extend from the outer tube.It was not possible to inject liquid when the slider was pushed.However, it was possible to inject liquid when the slider was pulled.The tube was buckled approximately at 285mm and 795mm from the distal end.The needle tube presented compressive buckling.The needle has no deformation.The manufacturing record was reviewed and found no irregularities.It is determined that liquid could not be injected due to compressive buckling of the needle tube.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: the tube was coiled during the inspection for operation the slider was pushed abruptly.The tube was buckled.A bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-use inspection.This might have caused the tube to buckle.Nm-401l series undergo 100% inspection for appearance, needle operation and injection during production process.Therefore, it can be inferred that handling the device at the facility might have contributed to the reported event.The above device handling has warned in the instruction manual.

• 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: 11034387
• Report Number: 8010047-2020-10641
• Device Sequence Number: 13779861
• Product Code: FBK
• UDI-Device Identifier: 04953170382345
• UDI-Public: 04953170382345
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 96K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1