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

Model Number 471205-17

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting the fenestrated bipolar forceps (fbf) instrument was stuck in the cannula due to a broken tip, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps (fbf) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated and confirmed the customer-reported complaint.The instrument was found to have a broken main tube.The broken main tube caused the cannula to be stuck on the instrument, but it was able to be removed during inspection.No scratches or damage to the cannula were observed.No material was found missing.The complaint regarding the fbf instrument becoming stuck in the cannula due to a broken segment was confirmed by failure analysis, which indicated that the device did contribute to the customer reported issue.A broken/cracked main tube is typically attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards leading to cracking and subsequent breakage.A review of the provided image was performed by an isi failure analysis engineer.The following additional information was provided: it looked like the instrument¿s proximal clevis had been dislodged from its normal position on the main tube.

Event Description

It was reported that during a da vinci-assisted abdominoperineal resection surgical procedure, the fenestrated bipolar forceps (fbf) instrument was stuck in the cannula due to a broken tip.A fragment fell into the patient and was retrieved during the same procedure.The fbf instrument was removed together with the cannula.The procedure was completed with no reported impact to the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.There was no port incision enlargement.The instrument is available for return.The cannula was not damaged.The damage was found only on the fbf instrument.The fbf instrument was returned with the cannula because it could not be removed from the cannula.The fragment was removed intraoperative by using the other forceps instrument.Visual inspection confirmed that all fragments were retrieved.Post-operative tests were not performed.No additional surgical procedure was performed.The patient did not return to the hospital due to any post-surgical complications.

• 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: 17145790
• MDR Text Key: 317447465
• Report Number: 2955842-2023-16384
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K10220131
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/22/2023

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: K10220131 0228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: No
• 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