FDA Adverse Event Malfunction Summary report: N

MARYLAND BIPOLAR FORCEPS INSTRUMENT

MDR report key: 2771258 · Received October 3, 2012

Report

Report Number: 2955842-2012-00493
Event Type: Malfunction
Date Received: October 3, 2012
Date of Event: September 5, 2012
Report Date: September 5, 2012
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K012833
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT ALSO PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. ON (B)(4) 2012, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. IT WAS INDICATED THAT NO PIECES FELL INSIDE THE PATIENT DURING THE LAST SURGICAL PROCEDURE THIS INSTRUMENT WAS USED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION IN CENTRAL PROCESSING, THE CUSTOMER NOTED A 'BROKEN WIRE' ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MARYLAND BIPOLAR FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420172-07	M10120322 961

Patients

Seq	Age	Sex	Outcome	Treatment
1				DA VINCI SI SURG SYSTEM, INSTRUMENTS & ACCESSORIE