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 No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2015

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 engineering evaluation) or if additional information is received.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci distal pancreatectomy procedure, allegedly, the endowrist one vessel sealer instrument intermittently cauterized patient's tissue.While there was no harm to the patient; recurrence of the alleged failure mode could likely cause or contribute to an adverse event if the failure mode were to recur.Review of the site's system logs for the reported procedure date found that no system errors were generated that would have caused or contributed to the reported issue.

Event Description

It was reported that during a da vinci surgical procedure, the endowrist one vessel sealer instrument worked intermittently and cauterized sometimes.The planned surgical procedure was completed and there was no report of any patient harm or adverse outcome.On 07/30/2015, intuitive surgical, inc.(isi) received additional information from the isi clinical sales representative (csr) who initially reported this complaint.According to the csr, the planned surgical procedure was a da vinci distal pancreatectomy procedure.The csr does not recall the tissue that was being sealed; however, during the sealing cycle audible tone was heard indicating that the sealing cycle was completed.The csr indicated that no error messages occurred during the sealing cycle.Tissue bunching in the jaws of the instrument was not observed.The csr indicated that the surgeon believes that the vessel sealer instrument failed to properly cauterize.No other information regarding the reported event was provided.

Manufacturer Narrative

Intuitive surgical, inc.Had performed a review of the site's system log and it was found that the reported endowrist one vessel sealer instrument was not used on 04/22/2015, which was previously reported in the initial mdr.At this time, the actual date of when the reported event occurred with the reported instrument is unknown.

• 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: 5033934
• MDR Text Key: 25401695
• Report Number: 2955842-2015-01139
• 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
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• 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: M11141208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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