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

Model Number 410322-05

Device Problems Failure To Adhere Or Bond (1031); Device Stops Intermittently (1599)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

The endowrist one vessel sealer instrument has not been returned to isi for failure analysis evaluation, therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be if additional information is received.Device history record (dhr) review-device history record (dhr) review for the device involved with this complaint has been completed.No non-conformances were identified to be related to this complaint.Based on the information provided, this complaint is being reported due to the following conclusion: during use of the endowrist one vessel sealer instrument, the patient's tissue was not properly sealed.While there was no patient harm, adverse outcome or injury reported, recurrence of the reported failure mode could likely cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci assisted low anterior resection (lar) procedure, the endowrist one vessel sealer instrument was not sealing properly.There was no report that any fragments from the endowrist one vessel sealer instrument fell into a patient during the surgical procedure and the planned surgical procedure was completed.On (b)(6) 2016, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) who initially reported this complaint.According to the csr, towards the end of the surgical procedure, the vessel sealer instrument functioned intermittently.During the instrument's sealing cycles, the audible tones were heard, with no tissue affect observed and other times the audible tones were not heard during the sealing cycle.The csr indicated that during initial use of the vessel sealer instrument, it worked fine.The tissue purchases taken by the surgeon were not > 7mm and when the sealing issues occurred no error messages or error codes were generated.There was no patient harm, adverse outcome or injury as a result of the vessel sealing instrument issue.The surgeon was able to complete the seals using the instrument in its intermittent state.

• 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: 5639432
• MDR Text Key: 45106408
• Report Number: 2955842-2016-00323
• 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
• Report Date: 04/21/2016

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: 410322-05
• Device Lot Number: M10151130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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