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

Model Number 410322-05

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The vessel sealer instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis) or if additional information is received.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that the vessel sealer instrument broke and a piece from the instrument fell into the patient.While the broken instrument piece was retrieved from the patient and there was no report of any patient harm, recurrence of the reported failure mode could likely cause or contribute to an adverse event.It is unknown what caused the instrument to break.

Event Description

It was reported that during a da vinci assisted surgical procedure, the vessel sealer instrument broke and a piece from the instrument fell into the patient.The broken instrument piece was retrieved.On (b)(6) 2018 intuitive surgical, inc.(isi) received additional information regarding the reported event from the site's robotics coordinator, who initially reported this complaint.According to the robotics coordinator, she was not present for the surgical procedure.She was told that during a da vinci assisted ventral hernia repair procedure, an unspecified piece broke off of the vessel sealer instrument and fell into the patient.The broken instrument piece was laparoscopically retrieved from the patient.It is unknown how long the instrument was in use prior to the instrument breakage issue.The instrument did not make contact with any other instrument during the surgical procedure and there was no observation that any lateral pressure was placed on the instrument while it was being used during the surgical procedure.The target tissue at the time of instrument breakage is unknown.There is no video recording and the surgeon does not know what may have caused or contributed to the broken instrument issue.According to the robotics coordinator, the planned surgical procedure was completed with a replacement vessel sealer instrument.There was no patient harm, adverse outcome or injury as a result of the instrument breakage issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed investigations.Failure analysis was unable to confirm the customer reported complaint.Visual inspection did not find physical damage to the instrument and there were no instrument pieces found to be missing.The instrument's limit switch was found to be dislodged, as a result the instrument failed homing and the blade became dislodged.The blade was dislodged 0.180.The limit switch was placed back in position and the instrument installed on an in-house system passed homing.Cut and seal functionality testing passed without an issue.Review of the instrument's logs found that 5 homing failures had occurred.Failure analysis investigations also found that the instrument's snake wrist was dislodged.It was concluded that the damage to the instrument's wrist was due to mishandling/misuse.No other damage was found.Based on the failure analysis investigation results, this mdr report is being retracted as it was determined that no fragment from the returned affected instrument fell into the patient and there were no missing instrument's components found to be missing from the instrument.

• 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 ; 4085232420
• MDR Report Key: 7170833
• MDR Text Key: 97730633
• Report Number: 2955842-2018-00011
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111116
• UDI-Public: (01)00886874111116(17)181031(10)M11161007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2018
• 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: M11161007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1