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

Model Number 410322-05

Device Problem Mechanical Jam (2983)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Isi has received the instrument involved with this complaint.Failure analysis investigations confirmed the customer reported complaint that the cut functionality of the vessel sealer was not working; however, investigation was unable to confirm that the instrument's sealing functionality was not working.The instrument failed self-check testing, due to the instrument's knife blade was found to be bent where the knife blade and cable interface, causing the knife blade to become stuck inside of the knife blade garage, thus preventing the blade from cutting the patient's tissue.Review of the site's system logs found that the instrument failed multiple cut attempts.The instrument passed electrical continuity testing.No other damage was found.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted hysterectomy procedure, at the completion of the vessel sealers sealing/cut cycles, it was noted that the patient's uterine arteries were not sealed.While there was no report of any patient harm, adverse outcome or injury, if the reported malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci assisted surgical procedure, the endowrist one vessel sealer instrument did not work.There was no report of any patient harm, adverse outcome or injury.No other information was provided.On 05/06/2016 intuitive surgical, inc.(isi) contacted the isi clinical sales representative regarding the reported event.According to the isi csr, the surgical procedure was a da vinci assisted hysterectomy.Midway through the procedure, the vessel sealer instrument stopped sealing and cutting.The surgeon had attempted to seal/cut the patient's uterine arteries; however, after opening the jaws of the endowrist one vessel sealer instrument, the surgeon observed that the patient's tissue did not exhibit any thermal affect and the tissue was not cut.The csr indicated the erbe generator tones occurred and the tones were normal throughout the sealing and cut cycles.There were no error messages or error codes generated during the instrument's sealing/cut cycles.A replacement endowrist one vessel sealer instrument was installed to complete the planned surgical procedure.There were no issues noted with the replacement instrument.The isi csr indicated that the patient had not undergone any previous chemotherapy or radiation treatments and the patient's arteries were not calcified and exhibited no abnormalities.

• 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: 5683923
• MDR Text Key: 47261974
• Report Number: 2955842-2016-00381
• 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: 04/28/2016

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 245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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