MAUDE MDR 3835688

MDR report key: 3835688
Report number: MW5036265
Event key: 0
Event type: 3
Date of event: 2014-03-21
Date received: 2014-05-21
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 2
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	TROCAR NEEDLE	TROCAR NEEDLE	COOK MEDICAL	FHP	DTN-18-20.0/G01377		4604646

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2014-05-21	0

Event Narratives#

D

Patient 1

DURING PERCUTANEOUS DRAINAGE OF ADNEXAL COMPLEX COLLECTIONS THE "STYLET" FOR THE TROCAR NEEDLE WOULD NOT PULL OUT. BOTH PIECES WERE REMOVED AND ANOTHER TROCAR NEEDLE WAS UTILIZED. AGAIN THE NEEDLE WOULD NOT PULL OUT. A THIRD ATTEMPT WAS MADE WITH A TROCAR NEEDLE WITH A DIFFERENT LOT NUMBER AND NO DIFFICULTY WAS NOTED. ALL WITH THIS LOT NUMBER WERE PULLED FROM THE SHELVES AND RETURNED TO THE COMPANY FOR REPLACEMENTS.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
03700393300622	NA	PETERS SURGICAL	FHP	2016-09-12
03700393300646	NA	PETERS SURGICAL	FHP	2016-09-12
03700393300615	NA	PETERS SURGICAL	FHP	2016-09-12
03700393300639	NA	PETERS SURGICAL	FHP	2016-09-12

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K910855	FHP	ENDOPATH VERESS NEEDLE	Symbiosis Corp.	1991-04-18
510(k)	K860102	FHP	MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE	Endotherapeutics	1986-02-12

MAUDE MDR 3835688

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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