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

Model Number 480322-06

Device Problem Device Stops Intermittently (1599)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

The endowrist vessel sealer instrument was returned for evaluation.Failure analysis did not confirm the reported complaint of the vessel sealer instrument sealing intermittently.The instrument delivered energy with no issues at all angles.There was no loss of power or intermittent energy observed.Grip force testing of all wrist orientations were found to be with in specifications.The instrument passed the electrode gap test and the gap was found to be within specifications.The instrument was found to have a dislodged blade.Visual inspection showed that the blade was exposed.163 outside of the blade garage.No conductor wire damage or snake wrist damage was found.There was minor bio debris found at the instrument tip and rails.After manually placing the blade in the track, the instrument passed the engagement and recognition test on an in-house da vinci system.The cut test passed and energy was delivered with no issues.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted colon resection procedure, the vessel sealer instrument did not seal the patient's tissue.While there was no report of any patient harm, recurrence of the reported failure mode could cause or contribute to an adverse event if the failure mode was to recur.It is unknown what caused the sealing issue.

Event Description

It was reported that during a da vinci assisted colon resection procedure, the endowrist vessel sealer was working and then stopped sealing.There was no report that any fragment(s) from the instrument fell into the patient and there was no report of any patient harm, adverse outcome or injury due to the sealing issue.The planned surgical procedure was completed.On 08/17/2016 an intuitive surgical, inc.(isi) clinical sales representative (csr) provided the following additional information.According to the csr, while the surgeon was using the endowrist vessel sealer on the mesentery tissue, the surgeon had a general feeling that the instrument was working for a while and then stopped sealing intermittently.Tissue effect was observed intermittently.During the sealing cycle the audible tones were heard coming from the erbe generator.At the end of the sealing cycle, the tones were also heard coming from the erbe generator.The tones coming from the erbe generator were normal.There were no error messages displayed on the erbe.He also confirmed that he doesn't believe the surgeon had attempted to seal a segment of tissue that was larger than recommended.The target tissue was not calcified and the surgeon did not encounter any obstructions such as clips, staples, bone or other hard objects between the instrument's jaws.

• 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: 5916200
• MDR Text Key: 54295215
• Report Number: 2955842-2016-00638
• 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: 08/02/2016

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: M10160609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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