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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); Stenosis (2263)
Event Type  Injury  
Event Description
Olympus reviewed the following literature titled "long-term outcomes of esophageal squamous cell carcinoma with invasion depth of pathological t1a-muscularis mucosae and t1b-submucosa by endoscopic resection followed by appropriate additional treatment". Literature summary: endoscopic resection (er) is indicated for a wide range of superficial esophageal squamous cell carcinomas (esccs)w. E examined the long-term outcomes in patients with pathological (p) invasion of escc into the t1a-muscularis mucosae (mm) and t1b-submucosa (sm) after er, for which data on prognosis are limited. Type of adverse events/number of patients: event 1:stenosis (mm 13. 9%, sm1 10. 7%, sm2 8. 7%), event 2:perforation (mm 1. 3%), event 3:delayed bleeding (mm 0. 6%), event 4:local recurrence(10), metastatic recurrence(8), regional ln metastatic recurrence(6), distant metastatic recurrence(3), ln metastasis detected in esophagectomy(4), overall metastasis(12), event 5:death due to escc(2), event 6:death due to other causes(49). The deaths have been determined to be not reportable. This article includes 2 reports: (b)(6) ae for kd-650l and (b)(6) ae for kd-612l. This is report 1 of 2 for (b)(6) ae for kd-650l.
 
Manufacturer Narrative
The subject device has not been returned. The legal manufacturer's investigation has been completed. The device history records (dhr) for this device could not be reviewed since the lot number was not provided. Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria. A definitive root cause was not identified. Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.
 
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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 Key14917184
MDR Text Key295259041
Report Number8010047-2022-11331
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
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 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
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 Received07/08/2022
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: 07/05/2022 Patient Sequence Number: 1
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