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 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

The endowrist vessel sealer instrument was returned for evaluation.Failure analysis did not confirm the customer reported complaint of the vessel sealer instrument sealing intermittently.The instrument delivered energy with no issues at all angles.The electrical continuity test and gap test passed.Grip test was also performed and passed.The instrument was placed on an in house da vinci system and passed the engagement and recognition test.The cut test passed and energy was delivered.Minor debris was found at the instrument tip and there was no snake wrist or conductor wire damage.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.

• 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: 5916209
• MDR Text Key: 54294908
• Report Number: 2955842-2016-00639
• 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: 08/10/2016

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: 08/10/2016
• 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