MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. FENESTRATED BIPOLAR FORCEPS INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420205-05

Device Problem Malposition of Device (2616)

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

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that prior to starting a da vinci surgical procedure, the fenestrated bipolar forceps instrument was not recognized by the system, and the tips didn't meet.There was no report of fragments falling into a patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation was unable to confirm the reported complaint of the instrument not being recognized.The instrument was checked for recognition on an in-house system.The system successfully recognized the instrument, showing 8 uses left.The pogo pins did not stick and were not contaminated.Failure analysis investigation found the following damages to the instrument: one grip was bent, causing side-to-side misalignment of the grips.There was a.110 offset at the tips, indicating overloading at the tip.It was concluded that the damage was likely due to mishandling/misuse.The instrument passed electrical continuity testing.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 grip cable was frayed at the distal idlers.No damage or wear marks were observed on the clevis.There were scratches on the surface of the pulley.The distal end of the main tube had various scratch marks exhibiting light material removal and a rough surface finish.The scratches were short 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 frayed cable and/or tube abrasions with material removed, found during failure analysis investigation, could likely cause or contribute to an adverse event, if the malfunctions were to recur.

• Brand Name: FENESTRATED BIPOLAR 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: 3773871
• MDR Text Key: 4362230
• Report Number: 2955842-2014-02568
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-05
• Device Lot Number: M11120730 608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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