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

Model Number	478059-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not received the crocodile grasper instrument for failure analysis investigation.Therefore, the root cause to the customer reported failure has not been determined.If additional information and/or the instrument is returned a follow-up mdr will be submitted to the fda.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, fragments from the crocodile grasper instrument broke and fell inside the patient.The fragments were retrieved, however, at this time it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy procedure, a piece from the crocodile grasper instrument broke inside the patient¿s abdomen.The broken instrument jaw that fell inside the patient was recovered easily while the other piece required an x-ray to determine its location.The missing piece was located and removed from the patient¿s abdomen.Upon inspection by the surgeon, the or personnel and the intuitive surgical, inc.(isi) clinical sales representative (csr) all agreed that all the missing pieces were recovered and no other instrument fragment was left inside the patient.Intuitive surgical, inc.(isi) obtained the following additional information from the isi csr: the csr confirmed that the or staff used a manual laparoscopic grasper to remove the broken fragments from the patient with no additional medical intervention.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCODILE GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7562563
• Report Number: 2955842-2018-10249
• Device Sequence Number: 13989212
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(10)S10170620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 478059-03
• Device Lot Number: S10170620 0132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1