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

Model Number NM-401L-0425

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

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 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.

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
• 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: 11034387
• MDR Text Key: 225929068
• Report Number: 8010047-2020-10641
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170382345
• UDI-Public: 04953170382345
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1