MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number 471205-17

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 04/25/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy procedure, the fenestrated bipolar forceps instrument was badly damaged whilst trying to remove it from tissue, causing an unspecified injury.The type of injury, any medical or surgical interventions required, that patient's status, and details regarding the damage to the instrument are currently unknown.The procedure was reportedly completed as planned.Intuitive surgical, inc.(isi) contacted the site to obtain additional information, however, at the time of this report, no further details have been provided.

Manufacturer Narrative

Based on the customer's claim against the product, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has not received the product for evaluation.If additional information is obtained, a follow-up mdr will be submitted.A review of the device logs for the fenestrated bipolar forceps instrument (part #: 471205-17 | lot #: k11230129-0106) associated with this event was performed.Per this review of the logs, the instrument was last used on (b)(6) 2023 via system sk4349 for a sigmoid colectomy procedure.There were 13 uses remaining after this last usage.There is no indication that the instrument was used in subsequent procedures after the alleged event reported in this record.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps associated with this complaint, and a failure analysis (fa) investigation was completed.Fa replicated and confirmed the customer reported complaint.The instrument was found to have one severely bent grip, causing misalignment of the grips.There was a 3.70 mm off-set at the tips.The grips also exhibited cracking damage.The components adjacent to the severely bent grip did not show damage.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 17051606
• MDR Text Key: 316431891
• Report Number: 2955842-2023-15621
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K11230129
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K11230129 0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: No
• 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