FDA.reportPublic FDA data

MAUDE MDR 5448361

MDR report key
5448361
Report number
1528319-2016-00005
Event key
0
Event type
3
Date of event
2016-01-21
Date received
2016-02-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS COLETTA COHARA
Address
5976 HEISLEY ROAD 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 IRRIGATORBIOPSY VALVEUNITED STATES ENDOSCOPY GROUP, INC.ODD00711133007111331518154N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-1901. O

Event Narratives#

N

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 BIOSHIELD IRRIGATOR WILL ALSO ALLOW FOR REMOTE IRRIGATION VIA AN ATTACHED IRRIGATION LINE. US ENDOSCOPY RECEIVED A REPORT FROM A (B)(4), THAT A BIOSHIELD LEAKED A LOT OF WATER. THE LEAKING OCCURRED DURING INSUFFLATION WITH AN IRRIGATION PUMP. THE STAFF WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. THE DEVICE WAS NOT RETURNED TO FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO MANUFACTURING OR QUALITY PROBLEMS AND ALL INSPECTIONS WERE COMPLETED WITH ACCEPTABLE RESULTS DOCUMENTED. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING REGARDING LEAKS: IRRIGATING THROUGH THE BIOSHIELD BIOPSY VALVE'S IRRIGATION LINE WITH A DEVICE IN THE BIOPSY CHANNEL REQUIRES SUFFICIENT SPACE BETWEEN THE DIAMETER OF THE DEVICE AND THE DIAMETER OF THE ENDOSCOPE'S CHANNEL. ADEQUATE SPACE IS REQUIRED TO ALLOW FLUID TO PASS FREELY AT A MODERATE PRESSURE SO THAT THE VALVE CONNECTIONS DO NOT LEAK. EXAMPLE: 2.3MM DEVICE IN A 2.8MM CHANNEL (SPACE .5MM) = INADEQUATE SPACE TO ALLOW FOR MODERATE PRESSURE DELIVERY OF FLUIDS; LEAKAGE MAY OCCUR. EXAMPLE: 2.3MM DEVICE IN A 3.2MM CHANNEL (SPACE .9MM) = SPACE IS INCREASED, KEEPING PRESSURE IN THE MODERATE RANGE, THUS LIMITING THE POTENTIAL FOR VALVE CONNECTION LEAKAGE. FOR PART #00711133 AND #00711137: LEAKAGE THROUGH NON-SHEATHED SPRING-COILED DEVICES SUCH AS BIOPSY FORCEPS WILL OCCUR IF IRRIGATION IS PERFORMED WHILE THE NON-SHEATHED DEVICE REMAINS IN THE BIOPSY CHANNEL. 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. DEVICE NOT RETURNED.

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 BIOSHIELD IRRIGATOR WILL ALSO ALLOW FOR REMOTE IRRIGATION VIA AN ATTACHED IRRIGATION LINE. US ENDOSCOPY RECEIVED A REPORT FROM A DISTRIBUTOR IN (B)(4), THAT A BIOSHIELD LEAKED A LOT OF WATER. THE LEAKING OCCURRED DURING INSUFFLATION WITH AN IRRIGATION PUMP. THE STAFF WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO REPORTED HARM TO THE PATIENT OR USER.