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

Model Number KD-V411M-0730

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 12/17/2014

Event Type  Death  

Manufacturer Narrative

The subject device was not returned to omsc for investigation since the subject device was discarded by the user facility.As the checking of the manufacturing record for past one year from occurrence date since the subject lot was unknown, nothing abnormal was detected.The investigating committee of the user facility finally reported that there were no problems about both ercp procedures.However, it was considered desirable if the hemostatic treatment for bleeding could have been accompanied with more careful check.In addition, the evaluation result was reported that the patient death was judged to be caused by septicemia due to prostatitis.According to the report, omsc assumes that not abnormality of the device but a procedural complication caused the bleeding.We guess the hemostatic treatment caused the re-bleeding.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus medical systems corp (omsc) was informed that the user facility performed endoscopic retrograde cholangiopancreatography (ercp) and endoscopic sphincterotomy (est) on a patient with cholangitis and hepatitis due to stone in common bile duct on (b)(6) 2014.During the est, the doctor observed bleeding.He performed a pressure hemostasis with a balloon and judged that it succeeded.In addition, he placed a larger diameter biliary stent into the patient for a larger hemostatic effect.Then, he completed the procedure.Before dawn on (b)(6), the patient developed melena and blood pressure reduction and he underwent hemorrhagic shock.Since re-bleeding was strongly suspected to be from the incision site of papilla, the doctor performed ercp again and a metal stent was placed into the patient.The metal stent fully expanded and additional bleeding was not observed.That afternoon, the patient's oxygen in the artery blood (spo2) and heart rate decreased and he suffered cardiopulmonary arrest.His cardiopulmonary functions restarted by receiving a blood transfusion and heart massage.The resuscitation temporary succeeded but the patient died of hypoxic encephalopathy on (b)(6) 2015.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME
• 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 6425177
• MDR Report Key: 5177246
• MDR Text Key: 29239025
• Report Number: 8010047-2015-00981
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Other
• Report Date: 09/28/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR