MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SMALL GRASPING RETRACTOR

Model Number	420318-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the part associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.The small grasping retractor instrument was found to have a broken pitch cable at the distal clevis hub.The broke cable segment that contains the crimp was still installed in the clevis.Failure analysis found the primary failure of a broken pitch cable at the distal end of the instrument to be related to the customer reported complaint.Root cause of a broken pitch cable is a component failure.A site history was performed and no other complaints related to this product were found.A review of system logs showed that the small grasping retractor was last used on system number (b)(4) on (b)(6) 2020 and it had 2 lives remaining.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: the small grasping retractor instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.Although no patient harm was reported, if the issue identified through failure analysis were to recur, it could potentially result in an adverse event.
Event or Problem Description
It was reported that during central processing, the small grasping retractor had a broken cable.There was no patient involvement.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11213844
• Report Number: 2955842-2021-10070
• Device Sequence Number: 14457419
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10190520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 420318-07
• Device Catalogue Number: 420318
• Device Lot Number: N10190520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1