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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-650U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Shock (2072)
Event Type  Injury  
Event Description
Olympus reviewed the following literature article: "propensity score matching analysis to evaluate efficacy of polyethylene oxide adhesive on preventing delayed bleeding after gastric endoscopic submucosal dissection" by yang yu, et al.   regardless of technical advancements, delayed bleeding is still a common adverse event after gastric endoscopic submucosal dissection (esd), often occurring in the early postoperative phase. This study aimed to evaluate the efficacy of a newly designed polyethylene oxide (peo) adhesive for preventing delayed gastric bleeding. Patients who underwent gastric esd between (b)(6) 2017 and (b)(6) 2020 at three chinese institutions were retrospectively reviewed. Patients receiving peo application on gastric post-esd ulcers were included in the peo group, and patients without this procedure were included in the control group. To minimize potential bias, propensity score matching was performed, and sex, age, lesion size, lesion morphology, ulceration, localization, procedure time, frequency of major intraoperative bleeding, resected specimen size, lesion histopathology, submucosal invasion and the taking of antithrombotic drugs were included as matching factors. The incidence of delayed bleeding and time to bleeding were compared between both groups. After propensity score matching, 270 patients (135 per group) were included in the analysis. The delayed bleeding rate in the peo group was significantly lower than that in the control group (1. 5%, 2/135 vs. 8. 9%, 12/135, p
=
0. 006). The median time (range) to bleeding was 4. 5 (4¿5) days in the peo group and 2 (1¿15) days in the control group, with no significant difference (p
=
0. 198). Peo demonstrated a significant effect in reducing the rate of delayed bleeding. Further study is warranted to confirm the efficacy of peo for bleeding that occurs in the early phase after gastric esd. Adverse events: n
=
1 experienced haemorrhagic shock on pod1 with transient tachycardia and hypotension, and he also received a blood transfusion because of a decrease in haemoglobin from 101 to 62 g/l. After endoscopic haemostasis and conventional medical treatment, the patient¿s condition stabilized on the same day, and he was discharged on. N
=
>14 - for patients with delayed bleeding, endoscopic haemostasis was successfully performed primarily with electrocoagulation for all bleeding sites. Metal clips were used as combined therapy for 5 lesions. Immediate haemostasis was achieved in all cases, and no re-bleeding events occurred later. N
=
4: major intraoperative bleeding was arteriolar bleeding or diffuse venous bleeding in which haemorrhagic sites could not be located for the first time. The article includes 6 reports: patient identifier (b)(6): kd-650u. Patient identifier (b)(6): gif-hq290. Patient identifier (b)(6): ucr. Patient identifier (b)(6): fd-411ur. Patient identifier (b)(6): nm-200l-0423. Patient identifier (b)(6): gif-q260j. This report is 1 of 6 for patient identifier (b)(6): kd-650u.
 
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. The literature article is attached for additional information. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
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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 Key14103863
MDR Text Key294495845
Report Number8010047-2022-06213
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650U
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/22/2022
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: 04/13/2022 Patient Sequence Number: 1
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