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

Model Number 410322-05

Device Problems Calibration Error (1078); Failure to Form Staple (2579); Failure to Cut (2587); Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

It was reported that during a da vinci hysterectomy procedure, the endowrist one vessel sealer instrument was not sealing correctly and then not cutting.After re-seating the instrument, the vessel sealer failed self-calibration.On (b)(4) 2015, intuitive surgical, inc.(isi) obtained following additional information about the complaint: the vessel sealer instrument was not sealing completely, it seemed to be not sealing like normal.The system did not give errors or messages.The surgical area was inspected and there was little tissue effect, it was kind of working in regards to sealing.Surgeon tried to seal several times then tried to cut and it was not cutting.There was no bleeding.Customer tried to re-seat the instrument and then it failed self-calibration.The procedure was completed using another energy instrument.There was no patient injury, harm or adverse outcome.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation found that the blade was exposed.The blade was manually brought out of the garage track and found that the blade was bent sideways, which would hinder the cutting performance.Functional cut test was not performed due to blade damage.The electrical continuity test was performed and passed.The reported complaint of not sealing could not be replicated.The instrument passed the jaw electrode gap inspection test in both soft and hard grip.The grip force was measured and the results were within specification range.This complaint is being reported due to the vessel sealer instrument not sealing correctly could likely cause or contribute to an adverse event, if the malfunction were to recur.

• Brand Name: ENDOWRIST ONE VESSEL SEALER INSTRUMENT
• 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 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 4633555
• MDR Text Key: 17337477
• Report Number: 2955842-2015-00484
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• 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: M10141208 907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: Initial
• Patient Sequence Number: 1