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

Model Number KD-620LR

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

Patient Problem Injury (2348)

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

On august 7th, 2019, olympus medical systems corp.(omsc) received a literature titled ¿value of endoscopic ultrasonography in diagnosis of gastric stromal tumor and the application of endoscopic submucosal excavation in the treatment of gastric stromal tumor¿.The literature reported that 29 procedures of endoscopic submucosal dissection (esd) were performed using olympus single use electrosurgical knife (kd-620lr or kd-611l) between december 2012 and october 2013.The literature reported that symptoms occurred as follows; mild bleeding: 29 cases.They were managed by ar.Gon plasma coagulation or hot biopsy.In one case small artery ejection bleeding occurred and hemostatic clip was used to close the bleeding.Perforation: 3 cases.The users were sealed by titanium clip and/or nylon ring.All patients received diet control, gastrointestinal decompression, anti-infection and other treatments.Conservative medical treatment was successful.Omsc tried to obtain further information such as the relationship between olympus device and all of the reported symptoms, but it is not obtained from the author of this literature at present.Therefore, according to the number of the type of symptoms known and the number of olympus device used for procedure, omsc is submitting 4 medical device reports.This is a report on mild bleeding associated with kd-620lr, and 1 of 4 reports.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 8954836
• MDR Text Key: 161259281
• Report Number: 8010047-2019-03166
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention