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Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc). The author has not provided additional information about individual cases. 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
The following events were reported in the j gastroenterol (2017) 52:1258-1265 article title: factors associated with delayed hemorrhage after endoscopic sphincterotomy: japanese large single-center experience, summary: during the endoscopic sphincterotomy which were performed between january 2011 and december 2015, clevercut 3v and needlecut 3v were used. The total number of patients were 1113 (male-to-female ratio was 643:470) the median age was 74 (range 14 - 101) years. In this retrospective study, 30 delayed hemorrhage cases were described. All cases were stopped bleeding with conservative treatment. The malfunction of the subject device has not been reported. This report is regarding clevercut 3v.
Manufacturer Narrative
This is a supplemental report to provide additional information. The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Omsc has not found any abnormality of the subject device in the pre-shipment inspection. Therefore, the exact cause of the reported event could not be conclusively determined. It is presumed that the bleeding occurred due to complication with performing the procedure. The instruction manual of the device has already warned as follows; do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end. If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result. 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 perforations, bleeding, or mucous membrane damage. Do not pull the slider abruptly, or the distal end of the insertion portion will bend rapidly. This could result in patient injury, such as perforations, bleeding, or mucous membrane damage. Do not tighten the cutting wire more than necessary, and do not force it against the papilla of vater. This could result in patient injury, such as perforations, bleeding, or mucous membrane damage. When applying the current, do not use an excessive/insufficient amount of conduction. 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.
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7761081
MDR Text Key116372722
Report Number8010047-2018-01570
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/08/2018 Patient Sequence Number: 1