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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-610L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
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 october 25, 2021, olympus medical systems corp. (omsc) received the literature titled "clinical outcomes of vonoprazan-treated patients after endoscopic submucosal dissection for gastric neoplasms: a prospective multicenter observation study". The purpose of this literature was to prospectively assess the efficacy of vpz in preventing delayed bleeding after gastric esd in comparison to ppis in this multicenter observation study. In the literature, it was reported as follows; the study comprised 253 consecutive vpz patients who underwent esd for gastric neoplasms between december 2016 and june 2018. In the ppi group, 385 consecutive patients with 385 gastric neoplasms took ppis during the esd period. The esd was performed using the following devices: it knife (kd-610l/kd-611l/kd-612l), dual knife (kd-650l/kd-655), needle knife (kd-1l-1), flush knife (dk2618jb/dk2618jn/dk2620j; fujifilm medical), sb knife (md-47706/md-47704/md-47703w; sumitomo bakelite), or clutch cutter (fujifilm co. ) and the vio300d (erbe). During esd, endoscopic hemostasis was performed using either the device itself or various hemostatic forceps, including a coagrasper (fd-410lr/fd- 412lr; olympus) or hemostasis forceps (hdb2418w; hoya), whenever active bleeding was noticed. Follows complications were reported. *stomachache vpz
=
9, ppi
=
20 *fever vpz
=
8, ppi
=
15 *intraoperative perforation vpz
=
3, ppi
=
5 *delayed bleeding vpz
=
10, ppi
=
9 *pneumonitis vpz
=
0, ppi
=
2 in addition, one patient in the vpz group and 2 patients in the ppi group required blood transfusions. These patients after discharge required hospitalization. Omsc assumes that these complications cannot be denied a relationship with the subject device due to the esd procedure used by the subject device. Based on the available information, omsc assumes that stomachache, fever, and pneumonitis were not serious injuries due to no information provided. Whereas, omsc assumes that the intraoperative perforation was a serious injury since the intraoperative perforation might be caused or contributed to a death or serious injury and 3 of delayed bleeding were serious injuries due to required blood transfusions and hospitalization. Therefore, omsc assumes that intraoperative perforation and delayed bleeding were adverse events to submit. Based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. Therefore, omsc will submit 2 medical device reports (mdr) of the subject device for intraoperative perforation and delayed bleeding. This report is 2 of 2. This report is regarding delayed bleeding required blood transfusions and hospitalization.
 
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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 Key12791950
MDR Text Key284144890
Report Number8010047-2021-14468
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170208546
UDI-Public04953170208546
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-610L
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: 11/11/2021 Patient Sequence Number: 1
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