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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 Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. The literature article is attached for additional information. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
Olympus reviewed the following literature: "second-look endoscopy (sle) findings after endoscopic submucosal dissection for colorectal epithelial neoplasms. " literature summary: this study aimed to investigate sle findings and their role in preventing delayed bleeding after colorectal esd. Among the 375 cases investigated, sles were performed in 171 (45. 6%) patients. The incidences of high-risk ulcer stigma and low-risk stigma were 5. 3% (9/171) and 94. 7% (162/171), respectively. During sle, endoscopic hemostasis was performed more frequently in the high-risk ulcer stigma group than in the low risk ulcer stigma group, but most of the endoscopic hemostasis in the high-risk ulcer stigma group (3/4, 75. 0%) were prophylactic hemostasis. Post-esd delayed bleeding occurred in three (0. 8%) patients belonging to the sle group, of which, one patient was from the high-risk stigma group and two were from the low-risk stigma group. The incidence of high-risk ulcer stigma during sle was low, and delayed bleeding occurred in, both, high-risk and low-risk groups of sle. Sles performed after colorectal esd may not be effective in preventing delayed bleeding, and further prospective studies are needed to evaluate the efficacy of sle in post-colorectal esd. Sle findings were retrospectively reviewed and categorized according to the forrest classifications: types ia (spurting), ib (oozing), iia (visible nonbleeding vessel), iib (adherent clot), iic (hematin on ulcer base), and iii (clean base). We classified types i and iia into a high-risk ulcer stigma group. Types iib, iic, and iii and clip closure were classified into a low-risk ulcer stigma group. During sle, endoscopic hemostasis was performed more frequently in the high-risk ulcer stigma group than in the low-risk ulcer stigma group (44. 4% [4/9] vs. 1. 9% [3/162], p < 0. 001). In the high-risk ulcer stigma group, endoscopic hemostasis was performed with hemoclips in one patient with an oozing ulcer (type 1b). For type iia ulcers (n
=
3), prophylactic hemostasis was performed with hemoclips (n
=
1) and apc (n
=
2). I post-esd delayed bleeding occurred in three (0. 8%) patients, who belonged in the sle group. In these three cases, all neoplasms were located on the rectum. Two patients with visible minor vessels on post-esd ulcers developed delayed bleeding 2 days post-esd. Sle findings were forrest types iia and iib, and prophylactic hemostasis was not performed during sle in both patients. On the day of the delayed bleeding, they underwent endoscopic bleeding control with hemoclips and apc, and bleeding spots could not be retrospectively matched to dots on ulcers on sle. Another patient underwent clip closure after completion of esd and developed delayed bleeding 4 days post-esd. During sle, as the ulcer was closed and there was no evidence of bleeding, prophylactic hemostasis was not performed. However, when bleeding occurred, some clips were not present, and bleeding was observed in the partially opened ulcer. Bleeding control was successful via hemoclips. No death or admission to intensive care units occurred. Type of adverse events/number of patients. Post-esd delayed bleeding - 3 patients. Oozing-type bleeding -1 patients. This article includes five (5) reports: patient identifier (b)(6): cf-q240al. Patient identifier (b)(6): cf-h260al was selected to represent cf-h260al or pcf-q260ji. Patient identifier (b)(6): fd-410lr. Patient identifier (b)(6): kd-620lr was selected to represent kd-620lr, kd-650l or kd-630l. Patient identifier (b)(6): hx-610-135l was selected to represent ez clip. This report is 3 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)
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 Key15099379
MDR Text Key296572499
Report Number9614641-2022-00029
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeKS
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 08/30/2022
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 Received08/02/2022
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
UNK LOT:HX-610-135L, UNKNOWN CAPS; UNK LOT:KD-620LR, KD-650L, OR KD-630L; UNK SERIAL:(B)(4).
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