MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. E653004 ELECTROSURGICAL SNARE

Model Number SD-Y0001-U15

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

Patient Problems Hemorrhage/Bleeding (1888); Pneumonia (2011); Renal Failure (2041); Cancer (3262); Unspecified Heart Problem (4454); Pancreatitis (4481)

Event Date 01/30/2022

Event Type  Death  

Event Description

Olympus reviewed the following literature, "the impact of the age-adjusted charlson comorbidity index as a prognostic factor for endoscopic papillectomy in ampullary tumors." literature summary: background the prognostic nutritional index (pni) and charlson comorbidity index (cci) have been useful for predicting the prognosis based on nutritional condition and comorbidities in surgery and endoscopic mucosal dissection.The age-adjusted cci (acci) has also been reported to be useful in surgery, but it has not been applied to endoscopic treatment.We therefore clarified the prognostic factors associated with ampullary tumors treated with endoscopic papillectomy (ep).Methods from january 2003 to december 2020, 236 patients who underwent ep for sporadic ampullary tumors at nagoya university hospital were included in this study.The 5-year survival and ability to predict the prognosis were evaluated in terms of the sex, pni, acci, final pathological diagnosis, and intraductal extension.Results during a median follow-up period of 1558 days, 17 patients died.No patient died of the primary disease.The 5-year survival rate was 91.1%.In a univariate analysis, only a high acci (> 5) was extracted as a significant prognostic factor (odds ratio, 12.2; 95% confidence interval, 3.81-39.3; p < 0.001).The 5-year survival rates for a low acci (< 4) and high acci were 96.6% and 73.5%, respectively (p < 0.001).Conclusions a high acci is an important prognostic factor associated with the 5-year survival and a risk of death from other illness.Ampullary tumors suitable for ep are less likely to be a prognostic factor, and treatment-free follow-up may be acceptable in patients with a high acci. the following adverse events were reported by the author: pancreatitis, postoperative bleeding, perforation, recurrence.Upon pursuit of additional information, the author reported no association between the olympus devices and adverse events.  the following deaths were reported: number of patients/cause of death noted.Deaths - during follow-up: 1 ampullary tumor; 2 were treatment related: 1 severe pancreatitis and 1 due to complications after pancreaticoduodenectomy; 8 other organ malignancies; 3 pneumonia; 1 cardiac disease; 1 renal failure; 1 subarachnoid hemorrhage; 1 sudden death.No patient died of the primary disease.Deaths - in endoscopic treatment: 15 due to other organ malignancy; 1 due to severe pancreatitis.Deaths - additional surgery group: 1 due to postop complications.There are 2 reports for this article: patient identifier (b)(6) tjf-q290v: patient deaths; patient identifier (b)(6) sd-y0001-u15: patient deaths.This is report 2 of 2 for patient identifier (b)(6) sd-y0001-u15: patient deaths; we selected "sd-y0001-u15" as a representative product for since the literature described "sd-y-0001".

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: E653004 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: 14376788
• MDR Text Key: 291589528
• Report Number: 8010047-2022-08146
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-Y0001-U15
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: TJF-Q290V,SERIAL UNKNOWN
• Patient Outcome(s): Death