MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. Single Use Electrosurgical Snare SD-400

Model Number	SD-400-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Melena (4480)
Type of Reportable Event	Serious Injury
Additional 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 lot 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 was no description of the device's malfunction.
Event or Problem Description
On october 25, olympus medical systems corp.(omsc) received the literature "management of less than 10-mm-sized pedunculated (ip) polyps with thin stalk: hot snare polypectomy versus cold snare polypectomy¿.The purpose of the literature was to evaluate whether the rate of delayed postpolypectomy bleeding (dppb) after cold snare polypectomy (csp) for ip polyps was higher than that after snare polypectomy (hsp) for ip polyps and compared other outcomes (the rates of immediate bleeding and pathological margins) between the hsp and csp procedures.The hsp and csp was performed using a snare (snaremaster-plus or snaremaster: olympus) and an endoscopy (cf-h260azi, pcf-q260azi, pcf-q290azi, or pcf-h290zi: olympus).Snare catheter was manufactured by unknown.In the literature, it was reported 3 immediate bleedings and 4 dppbs in hsp, and 39 immediate bleedings in csp.Dppb was defined as a fall in hemoglobin level by at least 2 g/dl below the most recent preoperative level or the need for endoscopic hemostasis and/or blood transfusion and/or massive melena.Immediate bleeding that necessitated hemostatic clipping was defined as spurting or oozing that continued for more than 30 s.The literature wrote, ¿all the episodes of immediate bleeding during csp were adequately controlled by endoscopic hemostasis, and none of the cases in this study required blood transfusion, admission, and/ or surgery.¿ based on the available information, a direct relationship between the olympus product and these complications could not be determined.According to harm list ver.19 (id: (b)(4), immediate bleedings in hsp and csp were decided as not serious injury.However, 4 dppbs in hsp that may have required blood transfusion and/or massive melena might be serious injury, and the olympus snare might be used when 4 dppbs occurred.This is the report regarding 4 dppbs in hsp that may have required blood transfusion and/or massive melena.

• Brand Name: Single Use Electrosurgical Snare SD-400
• Common Device Name: 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: 12826236
• Report Number: 8010047-2021-14667
• Device Sequence Number: 4571748
• Product Code: FDI
• UDI-Device Identifier: 04953170396694
• UDI-Public: 04953170396694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SD-400-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown