MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY SPATULA; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420184-11

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the permanent cautery spatula instrument for failure analysis.Therefore, the root cause of the customer reported failure mode cannot be determined.If additional information is received, a follow-up mdr will be submitted.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 a fragment broke off and fell inside the patient.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted procedure, the surgeon found fragments of plastic-like material in the mediastinal cavity.After careful examination of the surgical instruments used, it was confirmed that the fragments are from the cautery spatula.The fragments were removed and the patient cavity was carefully examined without finding any other fragments.An x-ray was conducted and it did not detect residual radiopaque foreign bodies in the thorax.The procedure was prolonged two hours and additional anesthesia was given.There were no reports of patient injury or harm.Intuitive surgical, inc.(isi) followed up with the reporter and obtained additional information about the complaint.The instrument was used 5 times.The surgeon had almost completed isolation of thymus (final part of dissection).The surgeon cleaned the spatula tip by touching it with the fenestrated bipolar, although he was told not to do so.The instrument was removed during the procedure for cleaning.Fragments were removed laparoscopically.Fragments were retrieved and radiography did not discover other fragments.There were no intra-op complications and the procedure was completed successfully.

Manufacturer Narrative

Failure analysis was able to confirm the customer reported failure.The permanent monopolar cautery spatula instrument was found to have a broken ceramic sleeve at the distal end of the spatula.Several uneven pieces of various shapes and sizes were returned with the instrument.Failure analysis determined that a fragment from the ceramic sleeve measuring approximately 0.049 by 0.049 was missing.Additionally, another fragment from the ceramic sleeve at the proximal end, measuring approximately 0.046 by 0.053 was also found to be missing.Based on the current information provided, this complaint will remain reportable due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment from the permanent monopolar cautery spatula instrument broke off and fell inside the patient.It was initially reported that all fragments were retrieved and no additional surgical intervention was required.However, failure analysis determined that some fragments were missing and not returned.At this time, the location of the missing instrument fragments is unknown.In addition, it is unknown if the missing instrument fragments were retained in the patient.

• Brand Name: PERMANENT CAUTERY SPATULA
• 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: 7174586
• MDR Text Key: 96939114
• Report Number: 2955842-2018-00016
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420184-11
• Device Lot Number: M10100218 647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR