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 12/10/2015

Event Type  Injury  

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.A supplemental report will be submitted, if additional and significant information becomes available at a later time.Please cross reference the associated complaint files: mfr report: # 8010047-2015-01322, 8010047-2015-01328 and 8010047-2015-01329.

Event Description

It was informed that the doctor found a large amount of bleeding in the patient during a polypectomy.The doctor attempted to stop the bleeding with the subject device.The doctor pressed the pedal of the high frequency generator, but the subject device could not be activated.Four subject devices in total could not be activated during the procedure.The doctor stopped the bleeding with the 5th device and 11 non-olympus clips.The patient had been hospitalized for 1 day due to heavy bleeding.This is the medical device report which is related to 1 of the 4 subject devices.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the evaluation of the returned device.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.Please cross reference the associated complaint files: mfr report: # 8010047-2015-01322, 8010047-2015-01328 and 8010047-2015-01329.

• 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: 5317244
• MDR Text Key: 34069621
• Report Number: 8010047-2015-01330
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FD-410LR
• Device Lot Number: K56250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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 Outcome(s): Hospitalization