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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-630L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corporation (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
On (b)(6) 2021, olympus medical systems corporation. (omsc) received the literature titled "endoscopic submucosal dissection of cecal lesions in proximity to the appendiceal orifice". This study was conducted on the endoscopic submucosal dissection (esd) for (b)(6) patients with cecal lesions in proximity to the appendiceal orifice from january 2003 to december 2014. In the literature, it was reported that one delayed bleeding, one patient of perforation and acute appendicitis, and one patient of abdominal pain and appendicitis occurred. The perforation, postoperative bleeding, and postoperative appendicitis were considered to be adverse events related to the procedure. The delayed bleeding was easily treated with endoscopic hemostasis. Whereas one patient who suffered perforation during esd was treated with clip closure near the appendiceal orifice, complained of abdominal pain 3 months after esd, and was diagnosed with acute appendicitis. The patient underwent emergency ileocecal surgical resection and recovered fully. Another patient complained of abdominal pain and was diagnosed with appendicitis 2. 5 months after esd. The patient was treated conservatively with antibiotic therapy and subsequently underwent an elective surgical appendectomy. Therefore, omsc assumes that two events need surgical intervention were an adverse event to submit. Based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. Omsc will submit one medical device reports (mdr) of the subject device for the adverse event need for surgical intervention.
 
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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 Key11500625
MDR Text Key241305267
Report Number8010047-2021-03834
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 literature
Reporter Occupation
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-630L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/01/2021
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 Unkown

Patient Treatment Data
Date Received: 03/17/2021 Patient Sequence Number: 1
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