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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-650L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 01/23/2018
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
During a esd(endoscopic submucosal dissection), the subject device(kd-650l) and fd-412lr were used by two operators. When one operator activated the subject device, the another operator who held fd-412lr was burned on the right arm. Treatment was not necessary for that burn injury. The intended procedure was completed with the subject device and fd-412lr. There was no other injury reported.
 
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation, because the subject device was discarded by the user. Therefore, the exact cause of the reported event could not be conclusively determined. Therefore, the exact cause of the reported event could not be conclusively determined. The lot number of the subject device is unknown. As a result of checking delivery record, we assumed the lot number is 7yk. The manufacturing record of the lot 7yk was reviewed and found no irregularities. This type of the event is most likely related to the operator's technique. Omsc presumes that the event occurred due to the following causes. When the operator who held the kd-650l activated output, the distal end of the fd-412lr which was held by another operator contacted with the distal end of the kd-650l. The handle of the fd-412lr or the gloves of the operator who held the fd-412lr were wet with conducting solution. High-frequency current was conducted through conductive solution such as saline. -the electrical cable which connected the kd-650l and the generator touched the operator who held the fd-412lr. The instruction manual of the device has already warned as follows; *when the instrument is used simultaneously with other accessories compatible with high-frequency current, do not activate output while the accessory is in contact with body cavity tissue or with this instrument. This may cause bleeding or thermal injury of the non-target tissue. *aspirate fluids such as mucus that adhere to the tube and body cavity tissue. Patient injury such as perforation, bleeding, mucous membrane damage and thermal injury of tissue could result if output is activated with these fluids adhering.
 
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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
MDR Report Key7291557
MDR Text Key100757543
Report Number8010047-2018-00307
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
PK092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650L
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/23/2018 Patient Sequence Number: 1
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