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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 Problems Perforation (2001); Stenosis (2263)
Event Date 01/04/2021
Event Type  Injury  
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.
 
Event Description
Olympus reviewed the following literature article: "utility of radial incision and cutting with steroid injection for refractory stricture after endoscopic submucosal dissection for large superficial esophageal squamous cell carcinoma" by jingyuan xiang.  this retrospective study was aimed to perform radial incision and cutting (ric) combined with steroid use to treat post- endoscopic submucosal dissection (esd) refractory stricture. Considering the systematic adverse events of oral administration, a local steroid injection is conducted during operation. The study enrolled 25 patients who accepted repeated endoscopic balloon dilation (ebd) because of refractory stricture after extensive esd for large superficial esophagus squamous cell carcinoma (sescc). The primary endpoints of the study were the incidence of recurrent stricture while the secondary endpoint was the following therapeutic ebd outcome, evaluated mainly by mean symptom-relief duration (msd) and valid symptom-relief period (vsp). The study reported that during the follow-up, the incidence of recurrent esophageal strictures was 92%, and perforation was observed in one patient. The study concluded that a combination of radial incision and cutting with steroid injection is a safe and feasible treatment for esophageal refractory stricture after extensive esd. Type of adverse events: stricture recurred: (n
=
23); intra-operation perforation: (1) one patient was found intra-operation perforation and the incidence of procedure-related adverse events was 4%. In this case, 8 ebd treatments had been performed in the past 163 days before combined treatment and tough fibrosis scar formed with severe adhesion. Perforation was sealed by several metal clips successfully and healed well under the follow-up endoscopy. Median number of 4 (median 0¿9) following ebd sessions were carried out for recurring dysphagia. This article includes 5 reports: patient identifier (b)(6): ucr; patient identifier (b)(6): kd-620lr; patient identifier (b)(6): gif-q260j; patient identifier (b)(6): fd-410lr; patient identifier (b)(6): nm-200l-0425. This report is 4 of 5 for patient identifier (b)(6): fd-410lr.
 
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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 Key14136799
MDR Text Key294608423
Report Number8010047-2022-06528
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
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 Received04/27/2022
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: 04/18/2022 Patient Sequence Number: 1
Treatment
UNKNOWN LOT NM-200L-0425; UNKNOWN LOT: KD-620LR; UNKNOWN SERIAL: UCR, GIF-Q260J
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