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

Model Number 410322-05

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

The instrument has not been returned for evaluation.The root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.Based on the information provided, this complaint is being reported due to the following conclusion: the endowrist vessel sealer instrument allegedly did not coagulate the patient's tissue.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 pancreatectomy procedure, coagulation stopped working on the endowrist one vessel sealer instrument.There was no allegation that any fragment(s) from the instrument fell into the patient and/or that any patient harm, adverse outcome or injury occurred involving the reported instrument.On (b)(6) 2015, intuitive surgical inc., (isi) obtained additional details from the initial reporter regarding the reported event.According to the isi clinical sales representative, the instrument's sealing function did not work right from the beginning.The generator did not display any errors or messages.A tone was heard however, the instrument was not sealing the tissue.Tissue effect was not observed during the procedure.The surgeon did not receive any audible sealing beeps or tones from the generator to indicate a complete sealing cycle.Since the instrument was not sealing, the surgeon did not use the cut function.The surgeon was holding the master grips tightly closed on the vessel and was in seal mode.The tissue being targeted was tissue bundle and the vessels were not in excess of 7mm in diameter or highly calcified.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation was unable to confirm the customer reported complaint of a sealing malfunction due to the instrument blade being exposed.The grip force test used to confirm sealing was not able to be completed to confirm or replicate the sealing function due to the exposed blade and the instrument snake wrist being dislodged.

• 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
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA
• MDR Report Key: 5274016
• MDR Text Key: 33356813
• Report Number: 2955842-2015-01469
• 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,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• 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: M11150214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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