MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

The monopolar curved scissor tip cover accessory 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 engineering evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.The lot # was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.This complaint is being reported based on the following conclusion: it was alleged that the monopolar curved scissors (mcs) tip cover accessory fell inside the patient during a da vinci assisted procedure.It is unknown if the fragment was retrieved during the same procedure with no patient injury.At this time it is unknown what caused the breakage to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment(s) falling into the patient may require surgical intervention.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the monopolar curved scissors (mcs) tip cover accessory was missing.The clinical sales associate (csa) called in from off site to ask if the mcs tip cover could be picked up on x-ray.Technical support engineer (tse) informed the csa that the tip cover was radiolucent and would not be picked up by x-rays.Csa informed the tse that site was still in the middle of the procedure and planning to look for the tip cover, but wanted to know if it would show up on x-ray.Csa was unable to provide additional information due to case ongoing.Tse requested that the csa call back in if site reports that they were able to find the missing tip cover.The csa reported no other issues during the procedure.There was no report of patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14247686
• MDR Text Key: 293854269
• Report Number: 2955842-2022-11318
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES