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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

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AOMORI OLYMPUS CO., LTD. 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 Hemorrhage/Bleeding (1888); Perforation (2001); Stenosis of the esophagus (4487)
Event Date 08/03/2021
Event Type  Injury  
Event Description
Olympus reviewed the following literature titled "long-term outcomes of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in taiwan. " the study is to evaluate the long-term outcomes of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in taiwan. Total of 229 lesions in 162 patients were enrolled. Forty-nine subjects developed complications, including six (2. 6%) with major bleeding, two (0. 9%) with perforation, and 41 (17. 9%) with strictures. Pathological staging showed that 19 cases had deep submucosal cancer invasion and subsequently received adjuvant therapies. During a mean follow-up period of 52. 6 (range 3¿146) months, 41 patients developed metachronous recurrence. The patients with a type c-d lugol staining back-ground pattern were associated with a higher risk of recurrence than those with few lvls. The 10-year survival rate was more than 90%, and only eight patients died of escc. Esd has excellent long-term outcomes but a high risk of metachronous recurrence. The lugol staining pattern over the background mucosa could offer the risk stratification of metachronous recurrence. Type of adverse events/number of patients: massive bleeding during esd - 2 patients; delayed bleeding - 4 patients; perforation during esd - 2 patients; post-esd esophageal strictures - 41 patients; died of escc - 8 patients. This literature article requires 2 reports. The related patient identifiers are as follows: (b)(6) kd-610l and (b)(6) fd-410lr. This medwatch report is for patient identifier (b)(6). The deaths were determined to be not reportable. There is no report of any olympus device malfunction in any procedure described in this study.
 
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)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA 036-0357
Manufacturer Contact
masaharu hirose
2-248-1 okkonoki
kuroishi-shi, aomori 036-0-357
JA   036-0357
426422891
MDR Report Key15092805
MDR Text Key296468735
Report Number9614641-2022-00027
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeTW
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 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
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 Received06/27/2022
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: 07/25/2022 Patient Sequence Number: 1
Treatment
KD-610L, LOT UNKNOWN
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