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

Model Number 480322-04

Device Problems Coagulation in Device or Device Ingredient (1096); Failure to Cut (2587)

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

Event Date 03/12/2015

Event Type  malfunction  

Event Description

It was reported that during a da vinci low anterior resection procedure, the surgical staff noted that the endowrist one vessel sealer instrument was not cutting or coagulating.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.There were no reports of fragments falling into the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of unable to cut or coagulate.Visual inspection showed heavy biodebris at the instrument tips.The cut and sealing passed the in house testing, but jaw gap test failed 0.001.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.System logs showed the instrument was working as expected but ended in a sequence of two errors, a failed cut followed by a blade jamming error.The customer reported complaint does not itself constitute a mdr reportable event; however; insufficient sealing, could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: ENDOWRIST ONE VESSEL SEALER INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL
• 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: 4737093
• MDR Text Key: 5886904
• Report Number: 2955842-2015-00645
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480322-04
• Device Lot Number: S10150206 0129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/01/2015
• 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
• Patient Age: 37 YR