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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-655

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655 Back to Search Results
Model Number KD-655U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/15/2021
Event Type  Injury  
Event Description
Olympus reviewed the following literature: "endoscopic full-thickness resection versus endoscopic submucosal dissection in the treatment of colonic neoplastic lesions
=
30 mm¿a single-center experience. "    literature summary. The purpose of the analysis was to evaluate efficacy and safety of full-thickness resection (ftr) in the treatment of colorectal lesions
=
30 mm by comparing prospectively followed ftr cohort to retrospective submucosal dissection (esd) cohort in the setting of single tertiary endoscopy center. Primary outcomes were technical success rate, r0 resection and curative resection rate, and complication rate. A total of 52 patients in ftr and 50 patients in esd group were treated between 2015 and 2018. Technical success rate was significantly higher in ftr group (92 vs. 74%, p
=
0. 01) as well as r0 resection rate (85 vs. 62%, p
=
0. 01) and curative resection rate (75 vs. 56%, p
=
0. 01). Complications occurred more frequently in esd group (40 vs. 13%, p
=
0. 002), mainly due to high incidence of electrocoagulation syndrome (24 vs. 0%). Total procedure time was substantially shorter in ftr group (26. 4 ± 11. 0 min vs. Estimated 90¿240 min). Local residual neoplastic lesions were detected numerically more often in ftr group (12 vs. 5%, p
=
0. 12). No patient died during follow-up. Compared to esd, ftr proved significantly higher technical success rate, higher r0 and curative resection rate, and shorter procedure time. In the ftr group, there were significantly less complications but higher incidence of local residual neoplasia. Further research including randomized trials is needed to compare both resection techniques. Perforation occurred in 1 case in the ftr and in 4 cases in the esd group. In both groups, there were 4 cases of delayed bleeding. In esd group, there were 20 cases of electrocoagulation syndrome while none in ftr group. Two cases of acute appendicitis following ftr of periappendicular lesions were treated conservatively. No patient died during this study and follow-up. Type of adverse events/number of patients. Ftr group. Perforation - 1 patient. Delayed bleeding - 4 patients. Acute appendicitis - 2 patients. Esd group. Perforation - 4 patients. Delayed bleeding - 4 patients. Coagulation syndrome - 12 patients. This article includes 8 reports: (b)(6): kd-650u - esd only group adverse events. (b)(6): kd-655u - esd only group adverse events. (b)(6): fd-411ur - esd only group adverse events. (b)(6): hx-110ur - esd only group adverse events. (b)(6): hx-201yr-135 - esd only group adverse events. (b)(6): d-201-14304 - esd only group adverse events. (b)(6): cf-h180al - for all adverse events. (b)(6): cf-hq190l - for all adverse events. This report is 2 of 8 for: (b)(6): kd-655u - esd only group adverse events.
 
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. 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 KD-655
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 Key14856900
MDR Text Key295041418
Report Number8010047-2022-11051
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K171158
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 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-655U
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 Received07/05/2022
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: 06/29/2022 Patient Sequence Number: 1
Treatment
UNK LOT: FD-411UR, D-201-14304; UNK LOT: HX-110UR OR HX-201YR-135; UNK SERIAL: CF-H180AL OR CF-HQ190L
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