MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER

Model Number	480322-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endowrist vessel sealer instrument involved with this complaint was returned for evaluation.Failure analysis was able to replicate/confirm the customer reported complaint.It was found that the plastic part of the instrument grip tip was broken.The broken piece returned was approximately 0.041" x 0.072" in length which measured up to the section missing from the grips and fit into the section on the grips where the gap is.A follow-up mdr will be submitted and or if additional information is received.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the surgical staff noticed a fragment on the patient's omentum.The fragment was retrieved without patient harm, adverse outcome or injury.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted nissen fundoplication procedure, it was alleged that ¿a small piece of dark plastic was found on top of the patient¿s omentum¿.The endowrist vessel sealer instrument was the only instrument that matched the color of the foreign body.The fragment was retrieved during the same procedure with an unspecified laparoscopic instrument.However, the site is not sure if there were any other fragments retained inside the patient.There was no report of patient harm, adverse outcome or injury.On 10-july-2018, intuitive surgical, inc.(isi) contacted the surgeon and gathered the following additional information: the surgeon was cauterizing tissue for 45 minutes with endowrist vessel sealer instrument when he saw a ¿piece of dark plastic¿ on the omentum.At that time, he removed the endowrist vessel sealer instrument and retrieved the fragment with an unspecified laparoscopic grasper.The surgeon confirmed the following; there were no collision of instruments, the wrists of the instruments were straightened when removed, and the instruments were inspected prior to use.The surgeon stated that ¿to the best of his human ability he looked to see if any other fragments were retained inside the patient; he did not find anything.However, he cannot confirm that there is no fragment retained inside the patient.The surgical staff believes that the fragment could be from the endowrist vessel sealer instrument, since that was the only instrument that matched the color of the fragment.However, when the surgical staff inspected the instrument they could not see any visible damage to the instrument.The planned surgical procedure was successfully completed and there were no intra-operative complications experienced by the patient.There is no video recording of the surgical procedure.The site did confirm they will be returning the instrument and the retrieved fragment.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale 94086
• MDR Report Key: 7747946
• Report Number: 2955842-2018-10425
• Device Sequence Number: 1319717
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200430(10)M11180426
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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
• Operator of Device: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: M11180426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other