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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 Hemorrhage/Bleeding (1888); Perforation (2001); Stenosis (2263)
Event Date 03/18/2021
Event Type  Injury  
Manufacturer Narrative
This report is being submitted to report the user's experiences and investigation findings. The devices referenced in this report were not returned to olympus for physical evaluation. The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided. Olympus does not ship any device that does not meet all design and safety specifications. Conclusion: no malfunction of any olympus device was reported in any procedure described in this article. From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.
 
Event Description
In the literature titled ¿real-world experience of endoscopic submucosal dissection for ulcerative colitis-associated neoplasia,¿ patients experienced adverse events after procedures using olympus devices. Case with patient identifier (b)(4) reports pcf-q260ji used in the procedures, case with patient identifier (b)(4) reports gif-q260j used in the procedures, case with patient identifier (b)(4) reports kd-650q used in the procedures, case with patient identifier (b)(4) reports d-201-11804 used in the procedures, case with patient identifier (b)(4) reports fd-410lr used in the procedures. Study background/aim: patients with ulcerative colitis (uc) have an increased risk of colorectal cancer. Some studies have recently investigated endoscopic resection of uc-associated neoplasia (ucan), but the indications for endoscopic resection of ucan remain controversial. This study sought to clarify the problems encountered in endoscopic submucosal dissection (esd) for ucan. Methods: seventeen lesions in 12 patients with ucan (ucan group) and 913 epithelial lesions in 824 control patients without uc (non-uc group) were evaluated. Both groups underwent esd between (b)(6) 2010 and (b)(6) 2017 at (b)(6) hospital, (b)(6). Treatment outcomes of the 2 groups were compared retrospectively results: univariate analysis showed that the mean tumor size was significantly smaller in the ucan group than in the non-uc group (25. 1 ± 26. 7 mm vs. 31. 9 ± 19. 0; p
=
0. 0023); however, the r0 resection rate was significantly lower in the ucan group (70. 6 vs. 92. 9%; p
=
0. 001). Multivariate analysis showed a significantly lower negative horizontal margin rate in the ucan group (odds ratio (b)(4) confidence interval 3. 588¿34. 525; p
=
0. 000). Conclusion: esd for ucan is associated with a low-negative horizontal margin rate. When performing esd for ucan, it is important to evaluate the accuracy of the ucan demarcation line, especially for flat lesions, using white-light imaging and chromoendoscopy as well as other modalities, including biopsy of surrounding tissues. Two of the 17 lesions ((b)(4)) were stenosed after esd; all lesions were treated with circumferential esd (table 3). One of the cases with stenosis after esd was a whitish, superficial elevated lesion extending from rb to ra. In this case, the anal side of the lesion was in contact with the squamous epithelium of the anus and was seen circumferentially. The oral side of the lesion had spread to ra for a maximum of two-thirds. Marking dots were placed with reference to the results of the peripheral biopsy done before esd. Esd was performed circumferentially on the anal side and involved three quarters of the circumference on the oral side. A total of 6 endoscopic balloon dilations were performed from 69 to 198 days after esd. In another case, esd was performed for a lesion with unclear margins in the sigmoid colon. Because the horizontal margin was positive pathologically, an additional esd procedure was per formed 10 days later. This patient underwent full-circumference esd that included the first esd ulcer. In total, 3 endoscopic balloon dilatations were performed in the 27¿ 46 days after the second esd. During a mean observation period of 28. 5 months, the local recurrence rate was 0%, the synchronous tumor rate was (b)(4), and the metachronous tumor rate was (b)(4). There is no report of olympus device malfunction described in this study.
 
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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 Key14346217
MDR Text Key294755694
Report Number8010047-2022-07956
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
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 Received05/17/2022
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: 05/10/2022 Patient Sequence Number: 1
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