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

Model Number 400180

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Neither the instrument nor the mcs tip cover accessory involved in this complaint has been received for analysis.Therefore the root cause of the reported customer issue has not been determined.If the products are returned and tested, and/or if additional information is obtained, a follow-up mdr will be submitted.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the device logs for the monopolar curved scissors (part# 470179-19 | lot-sequence# k14211213-0074) associated with this event has been performed.Per this review of the logs, the monopolar curved scissors was last used on (b)(6) 2022 during a cholecystectomy on system serial# (b)(4).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: it was reported that the instrument's insulation was damaged.If the mcs tip cover accessory was damaged and compromised, it is possible for energy to discharge in an area other than the instrument tip.Per the i&a user manual "it is important to exercise caution when using a energized endowrist monopolar curved scissors instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized." failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns.Although there was no allegation of patient injury related to the event, if the failure were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during central processing and cleaning, the instrument had insulation damage.There was no report of patient involvement, mitigating any patient injury.Intuitive surgical, inc.(isi) has performed follow-up to request additional information related to the reported event.However; as of the date of this report, no further details have been received.

• 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: 14047229
• MDR Text Key: 298482079
• Report Number: 2955842-2022-10925
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES