FDA.reportPublic FDA data

MAUDE MDR 9570497

MDR report key
9570497
Report number
MW5092138
Event key
0
Event type
3
Date of event
2020-01-06
Date received
2020-01-08
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
15 MM ENDO CLIP APPLIERAPPLIER, SURGICAL, CLIPCOVIDIEN LLCGDO176630J7C0772XI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-080

Event Narratives#

D

Patient 1

A PIECE OF ENDO CLIP APPLIER BROKE OFF WITHIN ABDOMINAL CAVITY WHILE IN USE. SURGEON WAS ABLE TO RETRIEVE THE SMALL PARTICLE. FDA SAFETY REPORT ID # (B)(4).