MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number UNKNOWN

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

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature title "single-center implementation of endoscopic submucosal dissection (esd) in colorectum: low recurrence rate after intention-to-treat esd".The literature reported the result of 83 cases of the endoscopic submucosal dissection intention-to-treat (esd-itt) using olympus instruments (unspecified dual knife, unspecified hook knife, unspecified coagrasper forceps and monofil snares) between november, 2009 and june, 2016.In the 83 cases of the esd-itt, the eight patients developed complications.Six patients developed transmural microperforations.Five of them recovered by tightly clipping without clinical consequences.One patient had a small retroperitoneal perforation in the hepatic flexure was diagnosed and tightly clipped with delay.After 12 hours, however, the patient underwent right-sided hemicolectomy because of rising inflammatory parameters in the presence of retroperitoneal and mediastinal emphysema.All of six patients were discharged within 10 days after the esd-itt.And one patient developed delayed bleeding, but recovered without long-term morbidity.In addition, one patient developed anorectal stenosis, but cured with two sessions of balloon dilation.Further detailed information could not be obtained from the user facility at present.According to the number of patients and devices, omsc is submitting 32 medical device reports.This report is 24 of 32 reports for anorectal stenosis at coagrasper forceps.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Type of Device: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 9796951
• MDR Text Key: 196393300
• Report Number: 8010047-2020-01662
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other