FDA Adverse Event Injury Summary report: N

ENDOWRIST

MDR report key: 18111313 · Received November 10, 2023

Report

Report Number: 2955842-2023-19838
Event Type: Injury
Date Received: November 10, 2023
Date of Event: July 28, 2023
Report Date: October 16, 2023
Manufacturer: INTUITIVE SURGICAL, INC
Product Code: NAY
UDI-DI: 00886874112441
PMA / PMN Number: K131861
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SMALL GRASPING RETRACTOR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR (SGR) INSTRUMENT HAD GRIP FAILURE. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE INSTRUMENT WAS INSPECTED FOR DAMAGE AFTER THE PROCEDURE. THE FRAGMENT FELL INTO THE PATIENT¿S ANATOMY, AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH A LAPAROSCOPIC INSTRUMENT. A POST-OPERATIVE TEST WAS PERFORMED, AND NO REMAINING FRAGMENT WAS OBSERVED. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1804089	ENDOWRIST	SMALL GRASPING RETRACTOR	NAY	INTUITIVE SURGICAL, INC	470318-10	K10230518 0005	00886874112441

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown		DA VINCI INSTRUMENTS AND ACCESSORIES