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

Model Number UNKNOWN

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

Patient Problems Anemia (1706); Myocardial Infarction (1969); Gastrointestinal Hemorrhage (4476)

Event Type  Death  

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

Olympus medical systems corp.(omsc) received a literature titled "a study of bleeding cases in endoscopic papillectomy (ep)".The literature reported the result of 28 patients with duodenal papillary lesions who underwent endoscopic papillectomy (ep) procedure using olympus electrosurgical snare sd-5l-1 or sd-6l-1 from january 2005 to december 2019.In the literature, it was reported complication as follows; (1) severe bleeding and death after 3 days of ep (1 case).(2) minor bleeding (6 cases)."severe bleeding and death" are described in the literature as follows."in the case where hemostasis was not achieved, a 7fr bile duct stent was placed after ep for a duodenal papillary adenoma.6 hours later, hematemesis occurred, and emergency endoscopy was performed.After 6 hours of hematemesis, emergency endoscopy was performed.Bleeding from the bile duct near the papilla was confirmed, and balloon compression, thrombin spraying, and additional 10fr bile duct stent placement were performed.The anemia did not progress, but there was much bleeding, and 4 units of irradiated red blood cell concentrate (rbc) were administered.After that, the anemia leveled off, but 3 days after ep, hematemesis and anemia (hb13.9¿9.9g/dl} were observed, and 4 units of rbc were administered, and emergency endoscopy was performed.Similar bleeding was observed, and balloon compression, thrombin application, two 10fr erbd stents, and 7fr enbd were performed, and hemostasis was confirmed.However, the patient went into cardiopulmonary arrest immediately after the stay in the air.At that time, his hb level was 7.7g/dl despite the blood transfusion, so we administered 8 units of rbc.We suspected myocardial infarction due to decreased cardiac function and performed emergency cag, but there was no significant stenosis in the coronary arteries.Cardiopulmonary resuscitation was performed, but there was no improvement, and the patient died and was discharged.Ischemia in the coronary arteries due to anemia was thought to be the cause." there are not mentioned that these complications were related to the subject device in question.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 assumes that "severe bleeding and death" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Therefore, omsc determined that the "severe bleeding and death" was adverse event to submit.Omsc will submit a medical device report (mdr) depending on the event.

• Brand Name: ELECTROSURGICAL SNARE
• Type of Device: 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: 12538195
• MDR Text Key: 273522095
• Report Number: 8010047-2021-12356
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955650
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death