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

Model Number NM-400L-0423

Device Problem Insufficient Information (3190)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿neurological symptoms and spinal cord embolism caused by endoscopic injection sclerotherapy for esophageal varices¿.The following is a summary of the literature: the patient who had (b)(6) had the ligation treatment of esophageal and gastric varices with tissue glue injection under intravenous anesthesia.Olympus single use injector model nm-400l-0423 and gastrointestinal videoscope model gif-q260j were used for the procedures.The procedure was completed and the patient returned to the hospital ward.Six hours after the procedure, the patient complained of the weakness and numbness in the lower limbs, abdominal distension and slight dysuresia.The patient's vital signs were stable, lower extremities were normal, the right limb muscle strength was iv level, and bilateral babinski signs were positive.The patient had magnetic resonance imaging (mri) of the thoracic and lumbar spine within twelve hours postoperation and spinal cord embolism was detected.Therefore, the facility stopped the hemostatic and coagulation regimen immediately and started nerve nourishment and microcirculation therapies, along with dexamethasone injections.Three months after this treatment, cervical and thoracic mri did not show any embolism in the spinal cord.The user states in the literature that spinal cord embolism is rare complication of endoscopic injection sclerotherapy.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Therefore, omsc will submit 2 medical device reports depending on the number of device.This report is a report of nm-400l-0423.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9716150
• MDR Text Key: 189434861
• Report Number: 8010047-2020-01361
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170259739
• UDI-Public: 04953170259739
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NM-400L-0423
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR