MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-210U-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

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.

Event Description

On october 29, 2020, olympus medical systems corp.(omsc) received literature titled "intra-abdominal bleeding as a rare complication after colonic endoscopic mucosal resection in a patient taking direct oral anticoagulants".This study was conducted the colonic endoscopic mucosal resection for one patient who was taking rivaroxaban as anticoagulants and had a medical history of atrial fibrillation.The mucosal resection was performed using the subject device.In the literature, it was reported post-emr intra-abdominal hemorrhage.The day after discharge, the patient experienced gradual pain in the right hypochondrium, and on day 4 after discharge, the abdominal pain worsened.A diagnosis of post-emr intra-abdominal hemorrhage was made, and the patient was immediately hospitalized.After hospitalization, two units of blood were transfused and fasting and fluid replacement started.The patient was discharged on the 8th day.Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the event and the subject device.However, omsc assumes that post-emr intra-abdominal hemorrhage might be related to the subject device since the subject device was used for mucosal resection.Therefore omsc assumes that post-emr intra-abdominal hemorrhage with hospitalization and transfusion might be a reportable serious injury.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) for the post-emr intra-abdominal hemorrhage with hospitalization and transfusion.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• 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 Key: 10834547
• MDR Text Key: 216100630
• Report Number: 8010047-2020-08890
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD-210U-10
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• 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: N
• Patient Sequence Number: 1
• Treatment: TAKING RIVAROXABAN 30 MG/DAY
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 36