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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 Problems Hemorrhage/Bleeding (1888); Perforation (2001)
Event Date 03/12/2022
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The investigation is ongoing. The definitive cause of the user¿s experience cannot be determined at this time. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
It is reported in the literature titled risk stratification of endoscopic submucosal dissection in colon tumors,¿ patients experienced adverse events after endoscopic submucosal dissection (esd) procedures using an olympus dual knife. Study aim: stratify the success rates of the esd procedure in the colon. Method: retrospective analysis of 601 patients who underwent esd procedure for colorectal neoplasm from 2016 to 2019 in center of bowel treatment, (b)(4). Excluding 335 rectal neoplasms, we selected 266 patients with lesions located in the colon. Results: lesions located in the left colon were characterized by the statistically higher en bloc resection and success rate, compared with the right colon¿87. 76% vs. 73. 95% (p
=
0. 004) and 83. 67% vs. 69. 75% (p
=
0. 007), respectively. The success rate was significantly lower in lesions with submucosal cancer, compared to low- and high-grade dysplasia (p < 0. 001). Polyps located in the right colon were characterized by a slightly higher complication rate compared to the left colon, without statistical significance¿13. 45% vs. 9. 52% (p
=
0. 315). Conclusion: results show that colonic esd has a high success rate, especially in the left colon, with a low risk of complications, slightly higher than in the right colon. Analysis of complications revealed esd procedure related complications in 30 (11. 27%) cases. Delayed bleeding was observed in eight patients (3%) and severe in two of them (0. 75%). Perforation occurred in 23 patients (8. 60%), but only in five cases required surgery (1. 87%). All cases of postoperative bleeding were successfully treated by an endoscopic procedure that entailed metal clipping and/or electrocoagulation, without the need to convert to open surgery. We have not found any deaths related to the esd procedure. There is no report of olympus device malfunction described in this study.
 
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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 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 Key14110754
MDR Text Key289251370
Report Number8010047-2022-06282
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650L
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 Received05/17/2022
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: 04/14/2022 Patient Sequence Number: 1
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