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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
Model Number KD-640L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pneumothorax (2012); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
This report is being submitted to report the user's experience and the investigation findings. The complaint device(s) were not returned to olympus for physical evaluation. The device history record (dhr) for the complaint device(s) could not be reviewed since the lot number was not provided. Olympus does not ship any device that does not meet all design and safety specifications conclusion: the definitive cause of the reported events could not be established. There was no report of any olympus device malfunction reported in any procedure described in this study, therefore it is presumed that the cause of the reported events is not related to the device.
 
Event Description
It is reported in the literature article titled "peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy, " five patients in the peroral endoscopic myotomy (poem) group experienced an adverse event. This was a retrospective single center review of 52 consecutive poem procedures between 2012-2014, and 52 consecutive rhm procedures between 2009-2014 with the primary aim of comparing the inpatient charges incurred by patients undergoing poem or robotic heller myotomy (rhm) for the treatment of achalasia. In all poem cases, an olympus kd-640l was used. There is no report of device malfunction during any of these procedures. Five patients in the peroral endoscopic myotomy (poem) group experiencing an adverse event (pneumothorax (1), mucostomies (4). No information was provided regarding any treatment required for these reported events. This report is being submitted to report the potential that an olympus device could have caused or contributed to a reported adverse event.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE
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 Key11582704
MDR Text Key255115195
Report Number8010047-2021-04306
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-640L
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/07/2021
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: 03/29/2021 Patient Sequence Number: 1
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