FDA.reportPublic FDA data

MAUDE MDR 6773387

MDR report key
6773387
Report number
1528319-2017-00020
Event key
0
Event type
3
Date of event
2017-06-26
Date received
2017-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS COLETTA COHARA
Address
5976 HEISLEY RD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOSHIELD BIOPSY VALVEBIOSPY VALVEUNITED STATES ENDOSCOPY GROUP, INC.ODD00711129007111291706932R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-0801. O

Event Narratives#

N

Patient 1

THE NURSE WENT TO EMPLOYEE HEALTH AND RECEIVED FIRST AID. REVIEW OF THE DEVICE HISTORY RECORD INDICATES NO ISSUES DURING MANUFACTURE; THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE SUBJECT DEVICE WAS NOT RETURNED TO US ENDOSCOPY. DEVICES FROM THE SAME LOT WERE RETURNED AND TESTED. THE DEVICES WERE CONFIRMED TO BE WITHIN SPECIFICATION. THE INSTRUCTIONS FOR USE DIRECTS THE USER TO "SECURELY PLACE THE BIOPSY VALVE ONTO THE BIOPSY/SUCTION CHANNEL OPENING" AND CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: "EXPOSURE TO BODILY FLUIDS MAY OCCUR DURING CONNECTION OR DISCONNECTION OF THESE DEVICES; ADHERENCE TO BODY SUBSTANCE ISOLATION PROTOCOLS IS THE RESPONSIBILITY OF THE USER. DO NOT LEAVE A DEVICE HANGING FROM THE VALVE. DOING SO CAN CAUSE THE CREATION OF A LARGER VALVE SLIT/HOLE THAT MAY CAUSE LEAKAGE. IF THE LID OF THE VALVE IS OPENED WHILE ATTACHED TO THE ENDOSCOPE DURING A PROCEDURE, SCOPE SUCTION WILL BE COMPROMISED AND LEAKAGE MAY OCCUR. IF LEAKAGE OCCURS, A STERILE GAUZE SHOULD BE USED TO COVER THE VALVE." IN-SERVICE TRAINING WAS PERFORMED AT THE USER FACILITY SITE.

D

Patient 1

THE BIOSHIELD? BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOSHIELD? BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE USER FACILITY REPORTED DURING A COLONOSCOPY PROCEDURE, THE BIOPSY VALVE CAME OFF THE ENDOSCOPE AND SPRAYED WATER CONTAINING BIOMATERIAL, SOME OF WHICH CONTACTED A NURSE.