FDA.reportPublic FDA data

MAUDE MDR 9908551

MDR report key
9908551
Report number
1717344-2020-00367
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
5920 LONGBOW DRIVE BOULDER CO 80301 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIGASUREELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIESCOVIDIEN MFG DC BOULDERGEILF1937LF1937* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, DURING ANTERIOR RESECTION OF RECTUM, AFTER SEVERAL ACTIVATION OF THE DEVICE, THE JAW OPENING AND CLOSING BECAME NOT SMOOTH. THE KNIFE DID NOT RETURN. THE JAWS COULD NOT BE RELEASED UNLESS FORCE WAS APPLIED TO THE FRONT OF THE HANDLE AND SO IT WAS STOPPED USING IT. THE DEVICE DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. REPLACED WITH ANOTHER SIMILAR DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

N

Patient 1

EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. THE REPORTED CONDITION WAS NOT CONFIRMED. THE JAWS OPENED AND CLOSED PROPERLY WHEN THE HANDLE WAS RETRACTED AND RELEASED. THE KNIFE BLADE ADVANCED AND RETRACTED SMOOTHLY ALONG THE KNIFE TRACK. THE KNIFE CUT OF THE DEVICE WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE KNIFE BLADE WAS ALSO INSPECTED UNDER MICROSCOPE AND NO ISSUE WAS FOUND. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) STATES, KEEP THE INSTRUMENT JAWS CLEAN. BUILD UP OF ESCHAR MAY REDUCE SEALING AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.