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

Model Number 410322-04

Device Problems Coagulation in Device or Device Ingredient (1096); Loss of Power (1475); Device Inoperable (1663)

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

Event Date 04/07/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci hysterectomy procedure, a yellow warning displayed and the endowrist one vessel sealer instrument had to be removed.The coagulation function of the instrument failed; a maryland bipolar forceps instrument was used instead.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.On (b)(4) 2014, intuitive surgical inc.(isi) contacted the nurse at the hospital to obtain additional information regarding the reported event.On (b)(6) 2014, the nurse replied indicating that the instrument functioned as intended for a little while, then the yellow warning was present and the surgeon realized that the sealing function was not working.She denied that the vessel was highly calcified or in excess of 7 mm in diameter.The surgeon was properly holding the master grips fully closed throughout the sealing cycle and did hear the two audible high pitch tones signaling that the generator had stopped applying energy.The sealing cycle was reported to be approximately 10-20 seconds long before the two audible tones were heard.The surgeon inspected the surgical area, but could see that the sealing was not functioning.It was confirmed that there was no patient injury.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation was unable to confirm the reported complaint.Upon initial inspection, the blade was not exposed.The instrument passed electrical continuity testing.A cautery and seal function test was performed with no issue.In addition, a grip force test was performed and passed.The gap between the grip was verified to be within the specification, but the grips had an offset of approximately 0.039 in the clockwise direction and 0.026 in the counter clockwise direction.Failure analysis investigation found that the snake wrist was dislodged.No missing pieces were observed.The instrument was placed on an in-house system; however, the instrument would not advance through the 8mm cannula due to the dislodged snake wrist.Therefore, a 13mm stapler cannula was used in order to perform vessel sealer cautery functional testing.Failure analysis investigation also found deep scratches with material missing at the grips.The surgace of the grips appeared to be scraped off in various areas.The customer reported complaint does not itself constitute a mdr reportable event; however, the damage to the instrument's snake wrist and the missing material at the grips found during failure analysis investigation could likely cause or contribute to an adverse event if the failure modes 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: 3953152
• MDR Text Key: 4645751
• Report Number: 2955842-2014-04501
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/01/2014

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: 410322-04
• Device Lot Number: S10130628 267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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
• Patient Age: 53 YR
• Patient Weight: 90