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

Model Number 410322-05

Device Problems Failure To Adhere Or Bond (1031); Device Stops Intermittently (1599)

Patient Problem Blood Loss (2597)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc., (isi) received and evaluated the instrument.Failure analysis investigations was unable to confirm or replicate the reported complaint.The instrument passed the self-check, electrode gap, and electrical continuity tests.The instrument also passed the energy activation test; steam generated when the seal pedal was pressed during a wet paper test, this confirmed active power and a complete energy circuit.Visual inspection confirmed there was no damage to the conductor wire.System logs also confirmed that there were several pedal durations for energy activation, and no errors generated.The customer reported complaint does not itself constitute a mdr reportable event; however, inadequate sealing could cause or contribute to an adverse event if the malfunction were to recur.

Event Description

It was reported that during a da vinci assisted colon resection procedure, the surgeon experienced sealing issues while using the endowrist one vessel sealer instrument.On (b)(6) 2016, intuitive surgical, inc.(isi) contacted the site's isi clinical sales representative (csr) and obtained additional information regarding the reported event.According to the csr, the patient underwent the planned surgical procedure due to chron's disease.During the use of the endowrist one vessel sealer instrument, the surgeon experienced intermittent sealing issues while sealing omentum tissue.After sealing/cutting the patient's tissue, the surgeon observed oozing blood coming from the surgical site.The csr did not recall how the surgeon was able to control the patient's oozing; however, a replacement endowrist one vessel sealer instrument was installed to complete the planned surgical procedure.The csr indicated that the patient's tissue was thick and inflamed.After the surgeon sealed the patient's tissue, he did not recall if the surgeon inspected he patient's tissue prior to cutting.During the instrument's sealing cycle, the audible tones were noted to have occurred and the audible tones indicating that the instrument's sealing cycle was complete were also heard.The csr indicated that patient did not require an intra-operative blood transfusion.However, it is unknown if the patient experienced any post-surgical complications as a result of the vessel sealing issue.

• 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: 5696199
• MDR Text Key: 47640138
• Report Number: 2955842-2016-00412
• 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: 05/10/2016

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: 410322-05
• Device Lot Number: M10151208 868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 35 YR