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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
Model Number KD-620LR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
On december 21, 2020, olympus medical systems corp. (omsc) received the literature titled "efficacy and safety of endoscopic resection for small submucosal tumors originating from the muscularis propria layer in the gastric fundus". This study was conducted endoscopic resection for 537 patients with small submucosal tumors between january 2013 to september 2016. In the literature, it was reported that 20 of pneumoperitoneum, 13 of hydrothorax, 16 of post-esd electrocoagulation syndrome(peecs), and 3 of bleeding. One of the 20 pneumoperitoneum patients was major pneumoperitoneum which required puncture and 19 patients with minor pneumoperitoneum, which only required observation. 13 hydrothorax patients suffered from thoracic effusion. 1 patient with major thoracic effusion required thoracic drainage and the remaining 12 patients with minor effusion did not require intervention. There were 16 patients with peecs who were administered intravenous antibiotics and fluids and whose oral food consumption was discontinued until symptoms improved. One of the 3 bleeding patients was major bleeding who underwent endoscopic hemostatic procedures. There were no treatment-related deaths. Based on the available information, detailed information of the subject device was not provided. Omsc will submit one medical device report (mdr) of the electrosurgical knife for serious adverse events that required intervention.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE
Type of DeviceSINGLE 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 Key11136789
MDR Text Key225766945
Report Number8010047-2021-01068
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-620LR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/21/2020
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

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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