MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CROCKODILE GRASPER

Model Number	478059-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The customer reported complaint was not confirmed.The reported symptom was not found related to the reported instrument.The returned instrument did not have visible cables.Additional information not reported by site: the instrument was found to have the plastic proximal clevis broken.The broken piece is missing as a result of breakage.Size of missing piece is approximately 0.186x 0.318.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the distal end of the instrument.As a result of the breakage, the grip tips were dislodged at the wrist and were returned with the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the crockodile grasper had a broken cable.The procedure was completing as planned with no reported injury.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCKODILE GRASPER
• 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: 17015669
• Report Number: 2955842-2023-14795
• Device Sequence Number: 6928670
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(10)N10190701
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 478059-04
• Device Catalogue Number: 478059
• Device Lot Number: N10190701 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown