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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-655Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)
Event Date 03/08/2022
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The investigation is ongoing. 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 article titled ¿prophylactic clip closure for mucosal defects is associated with reduced adverse events after colorectal endoscopic submucosal dissection: a propensity-score matching analysis¿ patients experienced perforation and/or bleeding events during or after procedures using olympus devices. Case with patient identifier (b)(6) reports kd-655q, case with patient identifier (b)(6) reports hx-610-090l, case with patient identifier (b)(6) reports hx-202ur, case with patient identifier (b)(6) reports pcf-h290z1, case with patient identifier (b)(6) reports pcf-q260ai. Study background and aim it is unclear whether prophylactic endoscopic closure after colorectal endoscopic submucosal dissection (esd) reduces the risk of postoperative adverse events due to variability in lesion characteristics. Therefore, we conducted a retrospective study using propensity score matching to evaluate the efficacy of prophylactic clip closure in preventing postoperative adverse events after colorectal esd methods: this single-center retrospective cohort study included 219 colorectal neoplasms which were removed by esd. The patients were allocated into the closure and non-closure groups, which were compared before and after propensity-score matching. Post-esd adverse events including major and minor bleeding and delayed perforation were compared between the two groups. Results: in this present study, 97 and 122 lesions were allocated to the closure and non-closure groups, respectively, and propensity score matching created 61 matched pairs. The rate of adverse events was significantly lower in the closure group than in the non-closure group (8% vs. 28%, p
=
0. 008). Delayed perforation occurred in two patients in the non-closure group, whereas no patient in the closure group developed delayed perforation. In contrast, there were no significant differences in other postoperative events including the rate of abdominal pain; fever, white blood cell count, and c-reactive protein; and appetite loss between the two groups. Conclusions: propensity score matching analysis demonstrated that prophylactic closure was associated with a significantly reduced rate of adverse events after colorectal esd. When technically feasible, mucosal defect closure after colorectal esd may result in a favorable postoperative course. The total number of adverse events after colorectal esd, including delayed perforation and post-esd bleeding, was significantly higher in the non-closure group than in the closure group (28% vs. 6%, p < 0. 001). Similarly, the proportion of patients with fever was significantly higher in the non-closure group than in the closure group (12% vs. 2%, p
=
0. 019). However, there were no significant differences in the proportion of patients with abdominal pain, wbc count, c-reactive protein levels, and appetite loss between the two groups. There is no report of any olympus device malfunction reported in any procedure described in this literature.
 
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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 Key14604937
MDR Text Key293379431
Report Number8010047-2022-09502
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170405631
UDI-Public04953170405631
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171158
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 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-655Q
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 Received06/07/2022
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: 06/06/2022 Patient Sequence Number: 1
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