MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HARMONIC ACE; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 480275

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

During intraop robotic hysterectomy, surgeon was using a harmonic ace curved shears (lot # m91200415, exp date 04/30/22, ref # 480275) and one of the tip prongs was broken while in use.A search for the broken part was done inside the patient and outside, but was not found.Surgical manager was informed and communicated with doctor that no x-ray needed, as per policy.However, he has to disclose the incident to the patient to which he agreed.Intuitive was called.As per operative note: "when the dissection of the vaginal cuff was performed, a small piece of the ace harmonic device was broken (distal active blade).We suspect went out to the vaginal cuff, but we were not able to identify it.At this time, the pelvic cavity was irrigated copiously with warm saline.No active bleeding was identified.The vaginal cuff was closed in a running fashion with 0 v-loc without complications.".

• Brand Name: HARMONIC ACE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12106630
• MDR Text Key: 259651577
• Report Number: 12106630
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2021

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: Other
• Device Model Number: 480275
• Device Lot Number: M91200415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA