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

Model Number 420227-03

Device Problems Bent (1059); Malposition of Device (2616)

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

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the customer noted that the pk dissecting forceps instrument had a bent tip and the tips would not meet.There was no report of fragments falling into a patient.There was no allegation of any harm, injury, or adverse outcome to a patient.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation found that the instrument tips were bent.One grip was bent, causing side to side misalignment of grips.There was a.035 offset at the tips.The grip tips did not meet together when fully closed.The instrument passed electrical continuity testing.It was concluded that the damages to the instrument's grip tip were likely due to mishandling/misuse.An additional observation not reported by the site was that the instrument's pitch cable was frayed at the distal clevis hub.The frayed strands stuck out at the wrist.Other cables at wrist were undamaged.No other damage was found.The endowrist instruments instructions for use (ifu) specifically states: general precautions and warnings handle instruments with care.Avoid mechanical shock or stress that can cause damage to the instruments.The customer reported complaint does not itself constitute a mdr reportable event; however; the damage to the instrument's pitch cable found during failure analysis investigation could cause or contribute to an adverse event if the failure mode were 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: 3843990
• MDR Text Key: 4413508
• Report Number: 2955842-2014-03370
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• 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: N10140304 693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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