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

Model Number FD-411UR

Device Problems Failure to Deliver Energy (1211); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for investigation.The exact cause could not be conclusively determined.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.A supplemental report will be submitted, if additional and significant information becomes available at a later time.

Event Description

It was informed that the doctor found a small bleeding during an endoscopic mucosal resection.Then the subject device was attempted to activated, but it couldn't.The doctor completed the procedure with another device.There was no other patient injury regarding this report.

Manufacturer Narrative

(b)(4).The subject device was returned to olympus medical systems corp.(omsc) for investigation.The subject device had no malfunction.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.The exact cause could not be conclusively determined.However, based on the cases in the past, it is known that failure of energization occur due to decreasing of the current density.It is known that the decreasing of the current density is caused by increasing of contact area between the tissue and the subject device.The instruction manual of the subject device warns; pulling the tissue when applying the current.This could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Type of Device: ELECTROSURGICAL HEMOSTATIC FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5277114
• MDR Text Key: 33038622
• Report Number: 8010047-2015-01180
• Device Sequence Number: 1
• Product Code: KGE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FD-411UR
• Device Lot Number: 57K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR