MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V

Model Number KD-V411M-0730

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The manufacturing history of the subject device was reviewed, with no irregularities noted.Therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information or the device is received a later time, this report will be supplemented.

Event Description

Olympus medical systems corp (omsc) was informed that during endoscopic sphincterotomy (est), knife wire was broken and caused damage to the intestinal wall immediately after activation.No additional information is available at this time.The doctor completed the procedure using another device.This is the first of the two reports of the sequential concerns occurred to the same patient caused by the subject device.This report describes the "the first event".Please cross-reference the following report; 8010047-2016-00794.

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 omsc for investigation on jul.12, 2016.The investigation confirmed that the cutting wire was broken.There were no other abnormalities related to the breakage in the subject device.Also as the checking of the manufacturing record of the same lot, nothing abnormal was detected.This type of damage is most likely related to the operator's technique.Based on the past similar cases, it is known that the cutting wire had point contact or came close to the tissue while activating, which caused a spark, and a part of the cutting wire became extremely hot, leading to the cutting wire breakage.Based on the past similar cases, omsc assumes that the intestinal wall was damaged because broken section of the cutting wire made contact with the tissue.The device instruction manual has warned users that "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 perforations, bleeding, or mucous membrane damage.".

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SPHINCTEROTOME
• 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 ; 42 6425117
• MDR Report Key: 5768071
• MDR Text Key: 48711128
• Report Number: 8010047-2016-00795
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KD-V411M-0730
• Device Lot Number: K5925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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): Other