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

Model Number NM-401L-0423

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

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

During an endoscopic mucosal resection, two of the subject devices were used (lot number: 81k and 9xk).For the device of lot number 81k, the needle did not come out from the distal end and the user was unable to inject liquid.For the device of lot number 9xk, the needle came out from the distal end but the user was unable to inject liquid.The procedure was completed with another device.There was no patient injury reported.This is the report regarding the device of lot number 9xk.

Manufacturer Narrative

This is a supplemental report to provide additional information.The lot number was corrected because it was wrong.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The factory of aomori olympus confirmed that fluid could not come out of the needle when the needle was extended from the distal end of the tube.The needle tube was compressive buckling.The manufacturing record was reviewed and found no irregularities.Based on the similar cases in the past, fluid might be unable to come out of the needle due to the compressive buckling on the needle tube.The compressive buckling on the needle tube was likely caused by the large friction between the sheath and the needle tube when the needle was extended.It was likely that the friction between the outer tube and the needle increased by the following factors.The tube was tightly bent during use.The slider was abruptly pushed.The above device handling has warned in the instruction manual as follows.Do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Operate the slider slowly, otherwise the tube could buckle.

• 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: 9896227
• MDR Text Key: 208208082
• Report Number: 8010047-2020-01884
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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
• Device Operator: Health Professional
• Device Model Number: NM-401L-0423
• Device Lot Number: K9X11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/29/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1