MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. None SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 400272

Device Problem Break (1069)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Adult male laparoscopic prostatectomy, bilateral pelvic lymph node dissection: tip of curved shears insert broke off in patient - was retrieved and saved. This incident was about midway through the procedure and another harmonic insert was utilized to complete the procedure. No issues with 2nd harmonic insert. This added an estimate of 5 minutes to retrieve the broken-off piece. Patient went to pacu in stable condition.

• Brand Name: None
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 13391966
• MDR Text Key: 284704813
• Report Number: 13391966
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2021,11/24/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 400272
• Device Catalogue Number: 400272
• Device Lot Number: M90200702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown