MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.

Model Number UNKOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blood Loss (2597); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

The malfunction of the subject devices concerning this case has not been reported.Also, since the serial numbers of these devices are unknown, olympus medical systems corp.(omsc) could not confirm the manufacturing history.Because the user facility recognized as complication in the conclusion of the report, this case is not the malfunction of device, it seems to be complication.But the exact cause of the reported event could not be conclusively determined.

Event Description

The following article was reported at (b)(6).Article title: the treatment results of endoscopic submucosal dissection (esd) in our hospital the article studied on the treatment results of endoscopic submucosal dissection (esd) which were total of 162 cases performed from april 2010 to february 2017.The two type of scope were used in these procedures: pcf-q260ji (from a transverse colon to a cecum) and gif-q260j (from a rectum to a descending colon) and a non olympus high frequency generator (vio300d) was used in combination with them.The parts of the treated bowel were a caecum (24 cases), an ascending colon (31 cases), a transverse colon (30 cases), a descending colon (7 cases), sigmoid colon (24 cases) and a rectum (46 cases).In the subject procedures, complications occurred as follows.- secondary hemorrhage: 4 cases (stop the bleeding in all cases) - perforation: 4 cases (the points of perforation were small, so stop the bleeding with a clip in all cases) - cancelled procedure because of muscularis externa traction: 1 case in this survey the percentage of successful mucosal resection at one time was 95.6%, and the percentage of curative resection was 97.5%.Esd performed at the investigated facility has been performed relatively safe.This is 2 of 8 reports.(secondary hemorrhage 4 cases and perforation is 4 cases).

Manufacturer Narrative

This supplemental report is submitted to correct "device product code.".

• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7016597
• MDR Text Key: 91913224
• Report Number: 8010047-2017-01714
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study,user facilit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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
• Patient Outcome(s): Required Intervention