MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420179-12

Device Problems Break (1069); Split (2537)

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

Event Date 03/12/2014

Event Type  malfunction  

Event Description

It was reported that prior to starting a da vinci surgical procedure, the orange tip of the monopolar curved scissors instrument tip was halfway broken, had a split.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.Nothing reportedly fell into the patient.

Manufacturer Narrative

The monopolar curved scissors instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation found instrument's tube extension broken and missing a piece measuring approximately.270 x.165 at the proximal clevis interface.The tube extension fractured next to one of the keys that mates with the proximal clevis.Failure analysis concluded that the tube extension breakage may have been due to mishandling.Failure analysis investigation also found that the instrument's tube extension had pad printing removed, measuring approximately.115' x.458.In addition, the tube extension had a dark purple discoloration towards the distal end.The tube extension did not feel different when touching the normal colored area vs.The discolored areas.It is unknown if the discoloration is due to reprocessing or from the pad printing application process.No other damage was found.Failure analysis concluded that the pad printing removal may have been due to mishandling.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 reportable event; however, the additional finding of the pad printing removal from the tube extension could likely cause or contribute to an adverse event, if the malfunction were to recur.

• Brand Name: MONOPOLAR CURVED SCISSORS 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: 3749613
• MDR Text Key: 4553412
• Report Number: 2955842-2014-02207
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050005
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420179-12
• Device Lot Number: M10131206 828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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