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

Model Number FD-410LR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Blood Loss (2597)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause could not be conclusively determined.A supplemental report will be submitted, if additional and significant information becomes available at a later time.

Event Description

During an endoscopic submucosal dissection, the doctor could not stop bleeding since the subject device was not activated.Therefore, the doctor stopped bleeding with another device and completed the intended procedure.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2017-00556 to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no defects on the subject device.The exact cause could not be conclusively determined.However, based on the similar cases in the past, it was known that failure of energization might occur because the current density decreased due to increasing of contact area between the tissue and the subject device.Also, the contact area between the tissue and the subject device might increase since the target tissue was soaked in water, the non-grasping section was come in contact with the tissue or the grasped tissue was too much.The instruction manual of the device has already warned as follows: 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.

Manufacturer Narrative

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

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6553448
• MDR Text Key: 74899458
• Report Number: 8010047-2017-00556
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FD-410LR
• Device Lot Number: K6Z280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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