MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PK DISSECTING FORCEPS INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420227-03

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the pk dissecting forceps instrument would not coagulate.Nothing reportedly fell into the patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.The customer was not sure of the date of the surgical procedure, but the instrument was given to him on (b)(4) 2014.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis was unable to confirm the reported complaint.The returned instrument was connected to a pk generator and passed a cautery test.The instrument passed electrical continuity testing.Failure analysis investigation found various scratch marks at the distal end of the main tube exhibiting light material removal.The scratches were approximately.031 -.163 in length and not axially aligned with the tube.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however, the tube abrasions with material removed found during failure analysis investigation, could cause or contribute to an adverse event, if to recur.

• Brand Name: PK DISSECTING FORCEPS INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3752224
• MDR Text Key: 21721219
• Report Number: 2955842-2014-02253
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K061260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420227-03
• Device Lot Number: M10130109 383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1