MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 400180

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

The mcs tip cover accessory was not returned to isi for evaluation.Therefore, the root cause of the customer reported issue cannot be determined.The mcs instrument was returned to isi and evaluated.The instrument's tube extension was found to be broken.The damaged area measured approximately 0.224 x 0.287.A broken off piece was not returned with the instrument.The known common cause of the failure is due to mishandling/misuse.The instrument tube extension was inspected for cracks and there were no cracks found.Isi has reviewed the site's system logs and determined that the mcs instrument involved with the reported event was last used on (b)(6) 2017, not (b)(6) 2017 based on follow-up information obtained on 12/08/2017.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment from the mcs tip cover accessory fell inside the patient.The fragment was 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 mcs tip cover accessory fragment to fall inside the patient.

Event Description

It was initially reported that during a da vinci-assisted surgical procedure, the tip of the monopolar curved scissors (mcs) instrument allegedly slipped and fell inside the patient's abdomen.On 12/08/2017, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event from the site: the mcs instrument was inspected prior to use.No additional anesthesia was administered due to the reported instrument issue.The instrument tip was found and removed during the same surgical procedure which reportedly occurred on (b)(6) 2017.In addition, no post-operative complications were reported.On 12/12/2017, isi contacted the site and confirmed that the instrument tip that allegedly fell inside the patient's abdomen was actually a mcs tip cover accessory and not an instrument fragment.

• Brand Name: TIP COVER ACCESSORY
• 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: 7199462
• MDR Text Key: 97920937
• Report Number: 2955842-2018-00032
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

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
• Device Operator: Health Professional
• Device Model Number: 400180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 56 YR