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

Model Number 400180

Device Problems Break (1069); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Image review: an image of the monopolar curved scissors (mcs) instrument was provided to intuitive surgical, inc.(isi).The mcs tip cover accessory was not installed on the instrument at the time that the image was taken.A review of the submitted image was performed by an isi failure analysis engineer (fae).The following additional information was provided: the submitted image identified an mcs instrument, no image of an mcs tip cover accessory was submitted for analysis.The fae confirmed no evidence of thermal damage visible on the mcs instrument.The mcs instrument exhibited grip cable breakage at the distal end.This observation is likely due to user mishandling.The mcs tip cover accessory has not been returned to isi for failure analysis.The mcs tip cover accessory is a single-use item and was likely disposed.Therefore, the root cause of the customer reported failure could not be determined.At this time, the condition of the mcs tip cover accessory used with the mcs instrument is unknown.A follow-up mdr will be submitted if additional information is received.Isi received the mcs instrument involved with this complaint and completed the device evaluation.The report of a broken grip cable was confirmed during failure analysis investigation.Inspection identified that the grip cable at the distal end was broken.The instrument was further inspected and the report of melting at the instrument base was not confirmed.No signs of thermal damage or melting on the instrument base, distal end or any part of the instrument was identified.The failure analysis results are consistent with the fae's analysis of the submitted photograph.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.System log investigation: a review of the instrument log for the monopolar curved scissors instrument lot# n10200330 / sequence 0330 associated with this event has been performed.Per logs, the instrument was last used on the reported event date of (b)(6) 2020 on system (b)(4).The alleged event occurred on the 9th use of the instrument.The instrument has 1 remaining usable life with no subsequent use recorded.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: the tip cover accessory, when used as intended, provides insulation over a section of the endowrist monopolar curved scissors instrument so that radio frequency (rf) energy is only available at the instrument scissor tips.The complaint reported melting at the mcs instrument base with no allegation of mishandling or misuse.The report of melting was not confirmed during failure analysis of the mcs instrument.Thermal damage on the mcs tip cover during the mcs instrument usage is unknown and could not be ruled out.Although there was no patient injury reported, if this failure were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during central processing, inspection of the monopolar curved scissors (mcs) instrument identified a broken grip cable and melting at the instrument base.No patient involvement was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: there was no report of arcing, thermal damage, or unintended energy discharge received during the last known instrument usage for a procedure on (b)(6) 2020 using system (b)(4).The site provided an image of the mcs instrument with the alleged reported issue.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10643843
• MDR Text Key: 244598764
• Report Number: 2955842-2020-11049
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: N10200330 0330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1