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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-645

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-645 Back to Search Results
Model Number KD-645L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Laceration(s) of Esophagus (2398)
Event Type  Injury  
Event Description
Olympus medical systems corp. (omsc) received a literature titled "long-term outcomes of per-oral endoscopic myotomy in spastic esophageal motility disorders: a large, single-center study". The literature reported the result of 74 patients with spastic esophageal motility disorders (semd) who underwent per-oral endoscopic myotomy (poem) procedure using olympus triangular tip knife and other device. In the literature, the following perforation have been reported to have occurred. Insufflation-related events (15 cases). Mucosal injuries (3 cases). Mucosal barrier failure (2 cases). Delayed bleeding (1 case). The literature states as follows, "adverse events were noticed in 21 (28. 4%) cases. Mild adverse events included insufflation-related events in 15 (20. 3%) and mucosal injuries in 3 (4. 1%) patients. Moderate adverse events included mucosal barrier failure in 2 (2. 7%) and delayed bleeding in 1 (1. 4%) patient. All the cases with mild adverse events were managed intraoperatively. The cases with mucosal barrier failure at the site of mucosal incision presented 10 and 14 days after the poem procedure with symptom of chest pain. Endoscopy revealed small defect at the site of mucosal incision between the endoclips. Both the cases could be managed with intravenous antibiotics, nil-per oral, and nasojejunal tube feedings for 5 and 7 days, respectively. In the case with delayed bleeding, there was a submucosal hematoma at the previous tunnel site. There were no signs suggestive of active bleeding, and the patient could be discharged after observation for 4 days. Gerd was detected in 36 (56. 1%) patients with 24-hour ph study. " based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. However, omsc assumed that the patients were hospitalized for the "mucosal barrier failure" because it was managed with nasogastric tube feedings. So, omsc determined that "mucosal barrier failure" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury. Also, the medical safety officer of the omsc commented that "delayed bleeding" is an observation hospitalization and is not serious, based on the following statement: "there were no signs suggestive of active bleeding, and the patient could be discharged after observation for 4 days. "there were no signs suggestive of active bleeding, and the patient could be discharged after observation for 4 days. " therefore, omsc determined that the "mucosal barrier failure" was adverse event to submit. Omsc will submit a medical device report (mdr) depending on the event.
 
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-645
Type of DeviceSINGLE USE ELECTROSURGICAL KNIFE
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 Key13067514
MDR Text Key285752749
Report Number8010047-2021-16688
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K182408
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-645L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2022
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 Unkown

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
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