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

Model Number 480322-07

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

The endowrist vessel sealer instrument has been returned to intuitive surgical, inc.(isi) for failure analysis invetigation; however, evaluation of the instrument has not yet been completed.At this time the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted after evaluation of the instrument has been completed.The complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the blade from the endowrist vessel sealer instrument broke off and fell inside the patient.Although there were no reported injuries as a result of the reported issue, at this time it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, a part of the endowrist vessel sealer instrument broke off and fell inside the patient.The broken fragment was retrieved with no patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative and obtained the following additional information: the csr confirmed that the blade from the endowrist vessel sealer instrument broke off and fell inside the patient.The blade fragment was retrieved with a unspecified laparoscopic grasper and the procedure was completed using another endowrist vessel sealer instrument.

Manufacturer Narrative

The instrument was returned to isi and evaluated.Failure analysis confirmed the reported complaint.The instrument was found to have a dislodged distal pin at the wrist, which was able to be completely pushed out.Visual inspection was conducted and found no damage to the pin.The pivot pin returned with the instrument was compared to a new pivot pin and it was observed that the pivot pin on the returned instrument was not swaged since it did not look mushroomed or deformed.Additionally, the knife was broken at the knife cable weld location.The broken knife likely occurred due to firing the blade on a hard object and/or tissue bundle, causing the knife cable to work-harden at the weld joint, become brittle and eventually break with continued use.Once the knife broke, the unswaged pin could slip out of the grips and fall out.The complaint is being reported due to the following conclusion: failure analysis confirmed that the pivot pin had not been swaged correctly which could cause or contribute to an adverse event if the malfunction were to recur.

• Brand Name: ENDOWRIST 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: 6891583
• MDR Text Key: 87472761
• Report Number: 2955842-2017-00629
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140189
• 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: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: S10170629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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