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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650 Back to Search Results
Model Number KD-650U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Event Description
On october 25, olympus medical systems corp. (omsc) received the literature "insulated-tip knife tunneling and c-shaped incision for esophageal endoscopic submucosal dissection: an initial western experience¿. The purpose of the literature was to investigate the feasibility and safety of it-knife tunneling and c-shaped incision esophageal esd in the (b)(6). All esd procedures were performed with an olympus (b)(4) upper endoscope (olympus) fitted with a disposable straight soft distal attachment ((b)(4); olympus). If submucosal fibrosis was encountered, esd technique would be converted to dualknife (b)(4); olympus) dissection for the fibrotic areas. A dualknife was used for making cautery markings around the lesion and an it-knife nano ((b)(4); olympus) was used for submucosal dissection. Blood vessel coagulation was performed with a coagrasper hemostatic forceps (b)(4); olympus). An electrosurgical generator and an injection needle were used, but the devices were non-olympus devices. In the literature, it was reported one case of an intraprocedural bleeding requiring one unit of packed red blood cells and one case of a delayed bleeding requiring emergency endoscopy. There is no more information about one case of an intraprocedural bleeding requiring one unit of packed red blood cells. The literature wrote, ¿there was one case with delayed bleeding requiring emergency endoscopy. This patient was a cirrhotic who did not require a blood transfusion but repeat endoscopy noted a bleeding submucosal vessel that was coagulated. ¿ based on the available information, a direct relationship between the olympus product and these complications could not be determined. However, one case of an intraprocedural bleeding requiring one unit of packed red blood cells and one case of a delayed bleeding requiring emergency endoscopy might be serious injury, and the olympus knife might be used when the cases occurred. This is the report regarding one case of an intraprocedural bleeding requiring one unit of packed red blood cells.
 
Manufacturer Narrative
The subject device was not returned to olympus. Therefore, the exact cause of the reported event could not be conclusively determined. Since the lot 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 was no description of the device's malfunction.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-650
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 Key12873097
MDR Text Key284898041
Report Number8010047-2021-15061
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170265785
UDI-Public04953170265785
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650U
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
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 Initial

Patient Treatment Data
Date Received: 11/25/2021 Patient Sequence Number: 1
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