MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 410322-05

Device Problem Device Stops Intermittently (1599)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

The endowrist one vessel sealer instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: the reported insufficient sealing could likely cause or contribute to an adverse event if the failure mode were to recur.

Event Description

It was reported that during a da vinci si colon resection procedure, the vessel sealer instrument was intermittently not sealing.Per reporter, the surgeon was attempting to resect carcinogenic mass and sealing vessels.The surgeon was in the seal mode, and got the sealing cycle tone that was about 2-3 seconds; reporter didn't think the sealing cycle was long or delayed.The surgeon did not see any tissue effect, blanching or steaming.Although there was no tissue effect, they heard the audible tones indicating sealing was completed at the end.The surgeon then released the jaws and observed that the vessel was not sealed.They plugged and unplugged the instrument and at times it worked, but 7 out of 10 times it did not work.The surgeon was sealing it twice as a precaution.The reporter believed that the tissues / vessels were not calcified nor skeletonized when he examined the mass post-operatively.The blood loss was minimal (around 100-150cc for the entire procedure), that did not require additional intervention.They did clean the instrument jaws intra-operatively.The surgeon did not attempt to seal over sutures or clips.Neither the system nor the generator gave any errors / warning messages.The reporter felt this to be more of a generator issue than the instrument issue as they had used another vessel sealer instrument that behaved in the same manner.This event has been reported via 'patient identifier number (b)(6).Isi technical field specialist had visited and examined the generator however did not find it out of specifications.It was replaced as a precaution.The planned da vinci procedure was completed and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the endowrist one vessel sealer instrument and completed its evaluation.Failure analysis investigation was not able to confirm or replicate the customer reported complaint of sealing intermittently.Visual inspection showed no sign of damage.The instrument was placed on da vinci in-house system, it was recognized and it passed self-test, cut and sealing test, electrode gap and force grip test.There was no damage to the instrument's conductor wire.System logs were checked and showed a disconnected error message related to the vessel sealer instrument and no other error messages.

• Brand Name: ENDOWRIST ONE VESSEL SEALER
• 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
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA
• MDR Report Key: 5096449
• MDR Text Key: 26835770
• Report Number: 2955842-2015-01228
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K110639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-05
• Device Lot Number: M10141128 033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2955842-01-26-2015-002-C
• Patient Sequence Number: 1