MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

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

Patient Problems Perforation (2001); Stenosis (2263)

Event Date 01/04/2021

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature article: "utility of radial incision and cutting with steroid injection for refractory stricture after endoscopic submucosal dissection for large superficial esophageal squamous cell carcinoma" by jingyuan xiang.   this retrospective study was aimed to perform radial incision and cutting (ric) combined with steroid use to treat post- endoscopic submucosal dissection (esd) refractory stricture.Considering the systematic adverse events of oral administration, a local steroid injection is conducted during operation.The study enrolled 25 patients who accepted repeated endoscopic balloon dilation (ebd) because of refractory stricture after extensive esd for large superficial esophagus squamous cell carcinoma (sescc).The primary endpoints of the study were the incidence of recurrent stricture while the secondary endpoint was the following therapeutic ebd outcome, evaluated mainly by mean symptom-relief duration (msd) and valid symptom-relief period (vsp).The study reported that during the follow-up, the incidence of recurrent esophageal strictures was 92%, and perforation was observed in one patient.The study concluded that a combination of radial incision and cutting with steroid injection is a safe and feasible treatment for esophageal refractory stricture after extensive esd.  type of adverse events: stricture recurred - (n=23).Intra-operation perforation - (1) one patient was found intra-operation perforation and the incidence of procedure-related adverse events was 4%.In this case, 8 ebd treatments had been performed in the past 163 days before combined treatment and tough fibrosis scar formed with severe adhesion.Perforation was sealed by several metal clips successfully and healed well under the follow-up endoscopy.Median number of 4 (median 0¿9) following ebd sessions were carried out for recurring dysphagia.This article includes 5 reports: patient identifier (b)(6): ucr.Patient identifier (b)(6): kd-620lr.Patient identifier (b)(6): gif-q260j.Patient identifier (b)(6): fd-410lr.Patient identifier (b)(6): nm-200l-0425.This report is 1 of 5 for patient identifier (b)(6): ucr. .

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.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

Additional information provided by the author: in the opinion of the author, there is no relationship between the olympus devices and adverse events in the study.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• 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: 14136764
• MDR Text Key: 294139093
• Report Number: 8010047-2022-06525
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081173
• 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: 05/25/2022

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: UCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/25/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOT NM-200L-0425.; UNKNOWN LOT: KD-620LR,FD-410LR.; UNKNOWN SERIAL (B)(6).
• Patient Outcome(s): Other