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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-611L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results. This report has been submitted by the importer under mdr # 2951238-2021-00425.
 
Event Description
The study involved patients with ulcerative colitis who had a restorative proctocolectomy treated with an ileal pouch to anal anastomosis (ipaa) surgery. Pouch stricture is a common complication in such patients. This study performed stricturotomy or balloon dilation to treat the pouch strictures (and afferent limb strictures). The patients were treated between 2008 through 2017. There were 40 patients treated with the stricturotomy and 160 patients treated with an endoscopic balloon dilation. The authors stated the strictures were treated with either a non-olympus needle knife or an olympus single use electrosurgical it knife2. Per the authors, strictures were incised circumferentially or radially until the adequate passage of the scope was achieved. The authors also stated the patients who received the stricturotomy were significantly older than the other group and the duration from the stricture diagnosis to the treatment was also longer in the stricturotomy group. The patients reported to have perforations were in the endoscopic balloon dilation group and an olympus device was not used. Stricturotomy group only, serious adverse events: 7 patients had post-procedural bleeding, 3 patients with procedure-related delayed bleeding requiring a transfusion.
 
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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 Key12578537
MDR Text Key275239918
Report Number8010047-2021-12737
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 Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-611L
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 Received03/28/2022
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: 10/05/2021 Patient Sequence Number: 1
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