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 Hemorrhage/Bleeding (1888); Perforation (2001); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The results of the legal manufacturer¿s investigation are included.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.The device was not returned for evaluation and the causal relationship between the events and device is not established.

Event Description

Olympus reviewed the following literature article: "chest pain after endoscopic submucosal dissection for esophageal cancer: the simple and clinically useful surrogate marker for transmural thermal injury by electrocoagulation" by makoto sakaia, makoto sohdaa, hideyuki saito, et al.  this retrospective study aimed to evaluate the association between chest pain and abnormal levels of inflammatory markers in the post-esophageal endoscopic submucosal dissection (esd) period and also investigated the clinical importance of chest pain to define the post-esophageal esd post-esd coagulation syndrome (cs).A total of 42 patients with thoracic esophageal cancer (ec) underwent esd.The study reported that the incidence of chest pain after esophageal esd is 35.7% and associated with elevation of wbc count on postoperative day 1 (wbc day 1) (p = 0.022) and the incidence of post-esophageal esd cs was estimated ranging from 11.9 to 54.8%.Two patients presented the delayed complications, viz., delayed bleeding in one, and stenosis in one.The study concluded that the incidence of chest pain after esd was only associated with postoperative elevation of wbc.  adverse events: overt perforation: n=1, defined as radiographic evidence of mediastinal emphysema after the procedure.Delayed complications: delayed bleeding[n = 1, stenosis n =1 muscle layer exposure n=12.This article includes 3 reports: patient identifier (b)(6): fd-410lr, patient identifier (b)(6): gif-q260j, patient identifier (b)(6): ucr.This report is 3 of 3 for patient identifier (b)(6): ucr.

Event Description

Additional information received from the author: no olympus devices malfunctioned and the adverse events were not caused by the olympus devices per the author.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author.

• 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: 14073987
• MDR Text Key: 294155573
• Report Number: 8010047-2022-06042
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/16/2022

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: 03/15/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other