FDA.reportPublic FDA data

MAUDE MDR 9589270

MDR report key
9589270
Report number
2027111-2020-00315
Event key
0
Event type
3
Date of event
2019-12-18
Date received
2020-01-14
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
WENDY KOBAYASHI
Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1C8701, S ALEXIS LAP SYS W/KII FIOS 5/BXRING (WOUND PROTECTOR), DRAPE RETENTION, INTERNALAPPLIED MEDICAL RESOURCESKGWC87011011358011338150R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-140

Event Narratives#

N

Patient 1

THE EVENT UNIT IS ANTICIPATED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 1 OF 2. COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 2 OF 2. THIS WAS DISCOVERED PRIOR TO SURGERY AND THERE WAS NO PATIENT CONTACT. WHEN THE DEVICE WAS PULLED FROM THE SHELF IT WAS NOTED THAT A PINHOLE WAS ON THE WHITE TYVEK SIDE OF THE POUCH ON EACH OF THE UNITS PULLED. IT IS UNKNOWN IF THE SAME LOT WAS PULLED FOR BOTH DEVICES. ONCE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT AVAILABLE FOR RETURN. THE OTHER UNIT IS AVAILABLE FOR RETURN. THE HOSPITAL HAS THIRD PARTY SOURCING WITHIN THE HOSPITAL AND THE DEVICES ARE REMOVED FROM THE OUTER CARTON AND PLACED ON THE SHELF BY MEDICAL STAFF FOR STORAGE. PHOTOGRAPHS ARE AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 19DEC2019 FROM APP. MED. ACCT. MGR.: 6 PHOTOS WERE PROVIDED. THE HOSPITAL IS [NAME] HOSPITAL ACCOUNT # (B)(4). PRODUCT: ALEXIS LAPAROSCOPIC SYSTEM (SMALL). 1 EACH OF PRODUCT # C8701, # LOT # 1338150. 1 EACH OF PRODUCT # C8701, # LOT # 1335750. PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: NA.