MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HOT BIOPSY FORCEPS

Model Number FD-1U-1

Device Problem Device Handling Problem (3265)

Patient Problem Blood Loss (2597)

Event Date 09/27/2011

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no defects affected to stopping bleeding.As the result of checking the manufacturing record, there was nothing abnormal found.The exact cause could not be conclusively determined.However, based on the evaluation and the reported situation, there might be bleeding because the user released the subject device from the tissue while the carbonized tissue was stuck to the subject device.The instruction manual of the subject device warns; always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding or mucous membrane damage.

Event Description

Olympus medical systems corp.(omsc) performed a mdr retrospective review and found that this report was required.The tissue was carbonized while the doctor stopped bleeding with the subject device.There was bleeding from the tissue again since the carbonized tissue was torn by the subject device.Therefore the doctor stopped bleeding with the clip.

• Brand Name: HOT BIOPSY FORCEPS
• Type of Device: HOT BIOPSY 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: 6269159
• MDR Text Key: 65453280
• Report Number: 8010047-2017-10053
• Device Sequence Number: 1
• Product Code: KGE
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FD-1U-1
• Device Lot Number: K1802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2011
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other