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Model Number KD-611L
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/02/2021
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. The lot number of the subject device is unknown. As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities. Based on opinions from the facility, it can be inferred that technique of handling the device might have contributed to the reported event. The instruction manual has warned as follows. Do not set the output value of the electrosurgical unit too high or too low. Also, do not allow the activation time to be too long or too short. Set the high-frequency output mode of the electrosurgical unit optimally according to the conditions of the tissue to be cut. An excessive or insufficient output value may result in perforation, bleeding, mucous membrane damage or thermal injuries to the non-target tissue. Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures. Excessive output level and time may result in patient injury, such as punctures, hemorrhages or mucous membrane damage. Application of high-voltage waveforms for extended periods increase the likelihood that it may break the cutting knife or crack the tip. When a high-voltage waveform has to be used, minimize the duration of current application. Do not angulate the endoscope¿s bending section of the endoscope abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope. This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage. Do not loop the a cord or bundle it with cables from other medical equipment (electrocardiograph, endoscopic video system, electrosurgical unit, etc. ). High-frequency signals and spark discharge noise during cauterization may cause malfunctions in other medical equipment that could have an adverse effect on the patient. Another possibility is that output from the electrosurgical unit will be abnormal and could cause patient injury, such as punctures, hemorrhages or mucous membrane damage. Do not cut the tissue by pressing the cutting knife or electrode on the mucosa forcefully. This could cause patient injury, such as punctures or hemorrhages. Do not use this instrument with the burnt tissue adhering to the cutting knife or electrode. This could cause patient injury such as punctures, hemorrhages, mucous membrane damage and thermal injury of tissue. It could also damage the cutting knife. Use the instrument removing the burnt tissue adhering. Be sure to check the output power of the electrosurgical unit before use. If the unit is used without the proper output setting, perforation, hemorrhages or mucous membrane damage may result. Do not continue using an abnormal electrosurgical knife to prevent perforation or hemorrhages. When applying the current, do not allow an excessive build up of heat in the surrounding tissue. Doing so could cause patient injury such as perforations and/or bleeding. When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure. Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient. This instrument can be incised by both the cutting knife and the electrode. When incising the tissue by pressing the knife forcefully more than necessary, unintended incision may occur by the electrode part, and it may cause perforation and massive bleeding. Always confirm the direction of incision and do not incise with more pressure than necessary.
Event Description
Our sales representative was present at the procedure of endoscopic submucosal dissection (esd) using the subject device, and reported that massive bleeding occurred due to damage to the patient's blood vessels. On (b)(6) 2021, at 15:00, esd was started. Around at 21:00, the blood vessels were damaged during the final submucosal dissection, causing massive bleeding. Around at 22:00, hemostasis treatment was started by a surgeon. Blood transfusion was also required. Around at 23:30, hemostasis was completed. The next day, a second look procedure was planed to check abdomen with endoscope and to perform the final esd depending on the patient's condition. It was reported that other products in combination with the subject device were esg-300 and gif-290t. The facility had not pointed out any problems with the devices. The physician in charge said it could have been caused by a technical problem.
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Manufacturer (Section D)
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
MDR Report Key11383388
MDR Text Key241120429
Report Number8010047-2021-03034
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-611L
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 Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1