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

Model Number 480322-06

Device Problems Failure to Cycle (1142); Device Stops Intermittently (1599); Mechanics Altered (2984)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the endowrist vessel sealer instrument involved with this complaint and completed investigations.Failure analysis investigations was unable to duplicate the customer reported failure mode.Visual inspection was conducted, and the instrument's snake wrist and conductor wire exhibited no damage.Minor debris was found at the instrument's wrist.The instrument installed on an in-house is4000 da vinci surgical system engaged successfully.Energy was delivered and the instrument passed continuity testing with no issues.The instrument also passed grip force testing.Review of the site's system log for the reported procedure date found no error codes associated with the reported complaint.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.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted colon resection procedure, the endowrist vessel sealer instrument sealed the patient's tissue intermittently.While there was no report of any patient harm, if the reported malfunction were to recur it could cause or contribute to an adverse event.It is unknown what caused the vessel sealing issue experienced by the site.

Event Description

It was reported that during a da vinci assisted colon resection procedure, the endowrist vessel sealer instrument functioned intermittently.There was no report that any fragments from the instrument fell into the patient and there was no report of any patient harm, adverse outcome or injury due to the intermittent functionality of the endowrist vessel sealer instrument.On may 9, 2016, intuitive surgical, inc.(isi) received additional information from the site's rn.According to the site's rn, the surgeon using the endowrist vessel sealer instrument to take down mesenteric fatty tissue when the reported sealing issue occurred.The endowrist vessel sealer instrument was in use approximately 30 seconds when it was noted that the instrument was not sealing the patient's tissue.The surgical staff unplugged and reseated the instrument and the issue was resolved; however, after 30 seconds, the issue recurred.During the instrument's sealing cycle, the audible tones were noted and at end of the instrument's sealing cycle the audible tones were noted to have occurred; however, during the sealing cycle there was no smoke observed coming from the instrument and there was no thermal affect to the patient's tissue.The site installed a replacement endowrist vessel sealer instrument to complete the planned surgical procedure.The site's rn indicated that patient's vessels appeared to be normal and there was no calcification of the patient's vessels noted by the surgeon.The patient had undergone previous radiation/chemotherapy in the pelvic area; however not in the area that was being mobilized with the endowrist vessel sealer instrument.The tissue in the jaws of the endowrist vessel sealer instrument did not appear to be > 7mm.There were no system faults or error messages generated when the sealing issue occurred.There was no noted bleeding experienced by the patient and the patient did not require any additional surgical procedure or blood transfusion as a result of the vessel sealing issue.The site's rn indicated there is no video recording of the surgical procedure and the surgeon did not indicate what may have caused or contributed to the sealing issue.

• Brand Name: ENDOWRIST 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: 5674914
• MDR Text Key: 46882018
• Report Number: 2955842-2016-00366
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K140189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2016

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: 480322-06
• Device Lot Number: M10160129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75
• Patient Weight: 68