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

Model Number SD-210U-25

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

Patient Problem Bowel Perforation (2668)

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

Olympus medical systems corp.(omsc) received a literature titled "snare tip is an alternative tool for colorectal endoscopic submucosal dissection".The literature reported the result of patients who underwent endoscopic submucosal dissection (esd) procedure using olympus sd-210u-25 and another device between january 2012 and november 2019.In the literature, the subject device is used for tumor resection in esd.In the literature, it was reported complication as follows; (1) immediate perforation (4 cases) (2) delayed perforation (1 case) (3) immediate bleeding (3 cases) (4) delayed bleeding (1 case) the literature states as follows, "all of the perforations in both groups were because of colonoscopic biopsy-related severe submucosal fibrosis which was performed at outside hospitals or clinics.One immediate perforation in the snare tip group and 3 immediate perforations in the dual knife group were closed with the endoclip securely.One delayed perforation occurred in the snare tip group 3 days later regardless of endoclip application and underwent laparoscopic repair successfully.In my personal opinion and experience (without clinical evidence in our data), when encountering severe submucosal fibrosis, the snare tip is too thick (1 mm) to perform the delicate dissection.On the contrary, the tip of the dual knife is much thinner (0.65 mm) and is more suitable to dissect the severe submucosal fibrosis.One immediate bleeding in the snare tip group and 2 immediate bleedings in the dual knife group were controlled by endoclip without blood transfusion.One delayed bleeding occurred 1 week after intake of anticoagulant for cardiovascular disease and was controlled by admission with parenteral fluid support." there are not mentioned that these complications were related to the subject device in question.However, omsc assumes that "delayed perforation" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury, as it was treated by laparoscopic repair surgery.Therefore, omsc determined that the "delayed perforation" was adverse event to submit.In addition, one case of delayed bleeding was judged not to be serious based on the advice of the medical safety officer (mso) of omsc.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.Omsc will submit a medical device report (mdr) depending on the event.

• 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: 12866423
• MDR Text Key: 283109115
• Report Number: 8010047-2021-14976
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SD-210U-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention