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 Failure to Anastomose (1028)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

The vessel sealer instrument has been returned to intuitive surgical, inc.(isi) for failure analysis investigation; however, evaluation of the instrument has not yet been completed.At this time the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted after evaluation of the instrument has been completed.The complaint is being reported because one of the reported vessel sealer instrument was not sufficiently sealing.Although there was no reported injuries as a result of the reported issue, this reported issue 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 assisted appendectomy procedure, after using the vessel sealer instrument to seal the patient's tissue to stop oozing, it was observed that the tissue was not sealed at the end of the instrument's sealing cycle.The site checked the jumper cable and the instrument control box and there were no issues noted.The site removed and re-installed the vessel sealer instrument; however, the issue persisted.A replacement instrument was installed; however, it did not work.The planned surgical procedure was completed and there was no report of any patient harm, adverse outcome or injury.On 11/05/2015, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) who initially reported this complaint.According to the csr, the surgeon was using the vessel sealer instrument to seal the edges of non-stapled tissue located near the patient's appendix.After installing the replacement vessel sealer instrument, it was noticed that it sealed intermittently.The surgeon made the decision to complete the surgical task using a permanent cautery hook instrument.The csr indicated that the tissue being sealed was choppy but was adequate for the instrument's jaws.The replacement vessel sealer instrument has been reported under mfr report 2955842-2015-01422.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed investigations.Failure analysis investigations was unable to replicate the customer reported failure mode.Evaluation found no trouble with the reported instrument.The instrument passed recognition and engagement testing and the instrument was found to move intuitively with a full range of motion in all directions.The instrument passed electrical continuity testing.The instrument was tested on a wet paper towel and smoke was observed coming from wet paper towel.The instrument also passed grip force and electrode gap testing.Review of the site's system log found that the returned vessel sealer instrument was in use for approximately 10 minutes, with a total of 28 seal events.The pedal duration times are in the range of 8s-10s, with the average pedal time being about 8.6s.There is one seal event with pedal duration of 24s.There are no partial cuts.This instrument was the second vessel sealer used in the surgical procedure.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.

• 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: 5249107
• MDR Text Key: 32243334
• Report Number: 2955842-2015-01421
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

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: 410322-05
• Device Lot Number: M11150804 572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1