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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 Abdominal Pain (1685); Fever (1858); Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation. The definitive cause of the user's experience cannot be determined at this time. The investigation is ongoing. This report will be updated upon completion of the investigation or receipt of additional relevant information.
 
Event Description
In the literature titled ¿fever and electrocoagulation syndrome after colorectal endoscopic submucosal dissection for patients with immunosuppressants and steroids¿, patients experienced adverse effects during and after colorectal endoscopic submucosal dissection (esd) procedures using a single use electrosurgical knife (kd-655). Study aim: assess the risk factors of post-esd fever and post-esd coagulation syndrome (pecs), focusing on the involvement of immunosuppressive drugs and steroids (im). Methods: this retrospective analysis of 510 patients who underwent colorectal esd at a single facility over a five-year period. The incidence rate, clinical outcome, and factors associated with post-esd fever and pecs were investigated. Results: post-esd fever and pecs occurred in 63 patients (12. 4%) and 43 patients (8. 4%), respectively. In multivariate analysis, the american society of anesthesiologists physical status >3, the use of immunosuppressants or prednisolone >5mg (im group), and injury to muscle layer/perforation were significantly associated with post-esd fever. In pecs, im group, tumors located on the right side, treatment time >60 min, injury to the muscle layer, and multiple lesions were independent risk factors. Both post-esd fever and pecs improved conservatively in the im group, and no serious complication was observed. Conclusions: the use of im was a risk factor for both post-esd fever and pecs. However, there were no serious complications in colorectal esd for patients taking im. Summary of adverse events: a total of 30 (5. 9%) patients had muscle layer injuries. Perforation occurred in 19 patients (3. 7%). The complete closure of the mucosal defect was performed in 311 patients (61%). Delayed perforation occurred in five patients (0. 9%). Seventy-five patients (14. 7%) experienced abdominal pain 63 patients (12. 4%) experienced fever after esd. Pecs occurred in 43 patients (8. 4%). Three cases (two cases, delayed perforation; one case, perforation during the procedure) required emergency surgery after esd because of peritonitis that could not be improved by observation treatment. There is no report of any olympus device malfunction in any procedure described in this study.
 
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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 Key13486909
MDR Text Key289731152
Report Number8010047-2022-02617
Device Sequence Number1
Product Code KNS
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 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
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 Received02/18/2022
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: 02/08/2022 Patient Sequence Number: 1
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