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

Model Number 471205-17

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 10/03/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted left hemicolectomy procedure, the patient underwent an open conversion to laparotomy to stop bleeding after observation of an injury to the inferior mesenteric artery (ima).The issue was caused by forceps operation under conditions with poor visibility.After conversion, hemostasis using an electric scalpel, resection of the lesion, and reconstruction of the gastrointestinal tract was performed.The blood loss amount is unconfirmed although blood transfusion was administered due to the event.The procedure was completed via laparotomy.The patient did not experience any post-operative complications.The patient¿s status is currently unknown.The system and instruments were inspected prior to use; no damage or abnormalities were observed.The surgeon does not think a da vinci system or instrument caused or contributed to the reported event.

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication cannot be determined.The fenestrated bipolar forceps involved with this event has not been received for failure analysis evaluation.Review of the instrument log showed that all multi-use instruments used in the case have been used in subsequent procedures with the exception of the single-use instrument.A site history review has shown that no complaints have been created for any of these instruments.Review of the advanced system log review found no errors related to the reported event.The logs from before and after the procedure were also reviewed, and there have been no other occurrences that would suggest faults related to the reported event.

• 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: 18051838
• MDR Text Key: 327125298
• Report Number: 2955842-2023-19778
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K11230420
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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: K11230420 0039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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.