ULTRATOME N/A 3080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-23 for ULTRATOME N/A 3080 manufactured by Microvasive/boston Scientific Corp..

Event Text Entries

[483] Pt. Scheduled for ercp, 5/20/92. Dx: abdominal pain, possible retained common duct stone. Using microvasive double lumen sphinterotome with valley lab. Electro surgery unit, settings cut #4/coag. #4, blend. Physcian using cut mode noticed large spark, wire broke. Procedure completed with non-disposable wire olympus sphincterotome with valley lab. Settings the same. The non-disposable wire also failed with a large spark and a nooticable large duodenal incision,. Physcian determined a perforation through x-ray. Pt. Admitted to hospital for observation for possible surgical repair. No repair required. Electrosurgery unit to biomedical engineering for possible malfunction test. No malfunction founddevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: none or unknown, none or unknown, none or unknown, incorrect technique/procedure. Conclusion: device failure occurred and was related to event, none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 782
• MDR Report Key: 782
• Date Received: 1992-06-23
• Date of Report: 1992-06-09
• Date of Event: 1992-05-20
• Date Facility Aware: 1992-05-20
• Report Date: 1992-06-09
• Date Reported to FDA: 1992-06-09
• Date Reported to Mfgr: 1992-06-02
• Date Added to Maude: 1992-06-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRATOME
• Generic Name: DOUBLE LUMEN SPHINCTEROTOME
• Product Code: HAM
• Date Received: 1992-06-23
• Model Number: N/A
• Catalog Number: 3080
• Lot Number: 48690
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-APR-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 765
• Manufacturer: MICROVASIVE/BOSTON SCIENTIFIC CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-06-23