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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 Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The investigation is ongoing. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
It is reported in the literature article titled ¿clinical and endoscopic features of acute hemorrhagic rectal ulcer, particularly in refractory and fatal cases. ¿; patients experienced adverse events during or after procedures using olympus devices. Case with patient identifier (b)(6) reports adverse events potentially related tocf-hq290i. Case with patient identifier (b)(6) reports adverse events potentially related to fd-410lr. Case with patient identifier (b)(6) reports adverse events potentially related to hx-610-090l. Background: acute hemorrhagic rectal ulcer (ahru), characterized by sudden painless and massive rectal bleeding in bedridden patients with severe comorbid illnesses, is increasingly being reported in asia, particularly in japan. Aim: we investigated the clinical and endoscopic features of ahru and the risk factors associated with a refractory and fatal course of this condition. Method: we retrospectively reviewed the records of 44 patients with endoscopically documented ahru between january 2016 and december 2017. We recorded the following data: (1) patients background. (2) endoscopic findings and hemostasis. (3) rebleeding after primary hemostatic treatment. (4) number of deaths. Results: (1) most patients were elderly individuals (median age 78 years). We observed a relatively high number of bedridden patients with eastern cooperative oncology group performance status 3 or 4 (n
=
37, 84. 1%). Comorbidities associated with ahru included cardiovascular (n
=
10), cerebrovascular (n
=
9), and orthopedic diseases (n
=
7). (2) the ulcerative patterns of ahru were endoscopically classified into the irregular (n
=
23), nearly circular (n
=
12), and dieulafoy-like (n
=
9) lesions. Hemorrhage that necessitated hemostatic intervention occurred in >50% of patients (n
=
25, 56. 8%); endoscopic placement of hemostatic clips was the most common method used (n
=
19). Most endoscopic primary hemostatic procedures were successful (96. 0%). (3) rebleeding occurred in 7 patients after endoscopic hemostasis. Steroid use was a risk factor for rebleeding after primary hemostasis (p
=
0. 008). (4) ten patients (22. 7%) with ahru died during hospitalization. Dialysis was identified as a risk factor for in-hospital mortality among patients with ahru (p<0. 001). Conclusion: endoscopic primary hemostasis was successful; however, some patients showed a refractory or fatal course. Notably, steroid use was a risk factor for rebleeding after hemostasis treatment, and dialysis was a risk factor for death in patients with ahru and a complicated clinical course. Seven cases (29. 2%) of rebleeding after primary hemostasis were observed. Rebleeding was defined as the presence of bloody stool again after endoscopic hemostasis and the need for emergency endoscopy. Endoscopic hemostasis was successfully performed in all but one patient who did not undergo endoscopy due to poor condition caused by underlying disease. As for hemostasis, the clip method was used in 5 cases and the electrocoagulation hemostatic method in 1 case. A third hemostatic procedure was performed in one case. Steroid use was detected as a risk factor (p
=
0. 008) when comparing the rebleeding group (7 patients) with the non-rebleeding group. There were 10 (22. 7%) deaths during hospitalization of patients with ahru; 6 cases were thought to be affected by ahru, 2 of which required colostomy due to refractory ulcers. 4 other patients were treated well with ahru but died due to worsening of their underlying disease. When risk factors for death were compared between the death group (10 patients) and the non-death group (34 patients), dialysis was detected as a risk factor (p<0. 001), while hemorrhagic shock, presence of blood transfusion, and rebleeding after hemostasis were not detected. There is no report of any olympus device malfunction reported in any procedure described in this literature.
 
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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 Key14644620
MDR Text Key294839355
Report Number8010047-2022-09734
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170208430
UDI-Public04953170208430
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 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
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 Received06/15/2022
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: 06/09/2022 Patient Sequence Number: 1
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