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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS Back to Search Results
Model Number FD-410LR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) of Esophagus (2398)
Event Type  Injury  
Event Description
Olympus reviewed the following literature: "randomized study of two endo-knives for the traction-assisted endoscopic submucosal dissection of early esophageal squamous cell carcinoma" by yoshiyasu kitagawa, et al. Abstract: needle-type devices, such as the dualknife (olympus, tokyo, japan), are widely used for traction-assisted esophageal endoscopic submucosal dissection (esd) but require a prolonged operation time. An improved model of the itknife (olympus), the itknife nano, may allow faster and easier esd than the dualknife. We conducted a randomized study to compare the performances of the dualknife and the itknife nano for traction-assisted esophageal esd. Patients with early esophageal squamous cell carcinoma were eligible for this study. The primary outcome was the total procedure time. The secondary outcomes were submucosal dissection time, en bloc, and complete resection rates, perforation rate, and adverse events. Results fifty patients were equally divided into two groups: the dualknife group (d-group) and the itknife nano group (i-group), and all underwent the assigned treatment. The i-group had significantly shorter total procedure time (36. 8 vs. 60. 7 min; p < 0. 01) and submucosal dissection time (17. 2 vs. 35. 8 min; p < 0. 01) than the d-group. The en bloc and complete resection rates were sufficiently high in both groups (100% and 100% in the d-group and 100% and 96% in the i-group, respectively). Significantly fewer hemostatic procedures due to intraoperative bleeding were performed in the i-group than in the d-group (0. 2 vs. 1. 4; p < 0. 01). Delayed bleeding, perforation, or esophageal stricture did not occur in either group. The itknife nano exhibited lower procedure time for traction-assisted esophageal esd than the dualknife, without increasing adverse events. Adverse events. Muscular layer exposure, n
=
7. The authors reporting using six (6) olympus devices during the study. This article includes 6 reports: (b)(6): (b)(4). (dualknife as the representative product). (b)(6): (b)(4). (b)(6): (b)(4). (b)(6): (b)(4). (b)(6): (b)(4). (b)(6): (b)(4). This report is 6 of 6: (b)(6): (b)(4).
 
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 HEMOSTATIC FORCEPS
Type of DeviceSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
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 Key14170810
MDR Text Key294639946
Report Number8010047-2022-06805
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062517
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
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFD-410LR
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 Received03/23/2022
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 Reuse

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
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