MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ITKNIFE; SINGLE USE ELECTROSURGICAL KNIFE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc).Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, we presume that the reported accidental symptom was not due to the malfunction of the device, but occurred as a general accidental symptom of the procedure.

Event Description

The following event was reported in gastrointestinal endoscopy vol.31 no.7; title "duodenal esd (endoscopic submucosal dissection) " summary.Delayed perforation occurred in one case after duodenal esd.Any of the following devices may have been used for the procedure.*itknife, dualknifej, hookknifej or non olympus's device.After making a full-circle incision and deep cutting for the lesion, the lesion was collectively resected by snaring.The exposed blood vessels were coagulated for the purpose of preventing post-bleeding.The day after the procedure, the patient developed abdominal pain and fever.The doctor performed an endoscopy on the patient.As a result, the doctor found the delayed perforation.The patient was treated conservatively and recovered.The treatment was the following.The administration of octreotide acetate.Fasting.The administration of antimicrobial agent.No further information was provided.This is the report regarding the occurrence of delayed perforation on itknife.

• Brand Name: ITKNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 8914268
• MDR Text Key: 155024205
• Report Number: 8010047-2019-02986
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention