MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISTAL ATTACHMENT

Model Number MAJ-296

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The legal manufacturer's investigation has been completed.The literature article can be found at: https://doi.Org/10.11280/gee.63.2508.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

Event Description

It is reported in the literature titled "study of 109 cases by endoscopic treatment (anti-reflux mucosectomy: arms) for acid secretion inhibitor (ppi) resistant refractory gastroesophageal reflux disease gerd) (with video) ", three patients experienced adverse effects during or after an endo-reflux mucosectomy (arms) using a disposable electrosurgical snare.Study aim: investigate the efficacy of arms in patients with ppi refractory gerd.Method: retrospective review of 109 patients with ppi refractory gerd who underwent arms and compared the questionnaire scores, acid-exposure times, number of demeester score, proximal reflux, and ppi discontinuation rates before and after arms.Results: subjective symptoms were significantly improved (p<0.01) and ppi could be discontinued in 40-50% of the patients after arms.In addition, improvement in subjective symptoms was maintained in the 3-year follow-up patients.Acid-exposure time or demeester score improved after arms (p<0.01), but proximal reflux did not improve significantly (p=0.0846).Conclusion: arms is a valuable minimally invasive treatment for people with ppi refractory gerd.The effectiveness of treatment is due to inhibition of acid reflux by scar formation in the cardia.Two postoperative bleeding events occurred in patients.These patients were treated with endoscopic hemostasis without the use of blood transfusions.Minor perforation was observed in one patient.This patient was treated with endoscopic clip closure of the defect.No additional consequences to the patients were reported.There is no report of any olympus device malfunction in any procedure described in this study.[type of adverse events / number of patients] postoperative bleeding 2 cases.Small perforation 1 case.This article includes 3 reports: (b)(6)/sd-221l-25.(b)(6)/gif-q260j.(b)(6)/maj-296 this report is 3 of 3 for (b)(6)/maj-296.

• Brand Name: DISTAL ATTACHMENT
• Type of Device: DISTAL ATTACHMENT
• 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: 14845091
• MDR Text Key: 294957155
• Report Number: 8010047-2022-10955
• Device Sequence Number: 1
• Product Code: FDS
• 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,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2022

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 Operator: Health Professional
• Device Model Number: MAJ-296
• 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
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 06/28/2022
• 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
• Treatment: UNK LOT, SERIAL: SD-221L-25,GIF-Q260J
• Patient Outcome(s): Other