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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 471172-16
Device Problems Thermal Decomposition of Device (1071); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Manufacturer Narrative
An rma has been issued to the customer requesting to have the instrument returned; however, isi has not yet received the maryland bipolar forceps for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if additional information is obtained. A review of the device logs for the maryland bipolar forceps (part# 471172-16 | lot/serial# (b)(4)) associated with this event has been performed. Per this review of the logs, the maryland bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4). There were 9 uses remaining after this last usage. No photo or video was provided by the site for review. This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. At this time, it is unknown what caused the thermal damage to occur. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Field is blank because the product is not implantable. Information for the blank fields is not available. Fields are not applicable.
 
Event Description
It was reported that during a da vinci-assisted liver resection surgical procedure, the maryland bipolar forceps cable was noted to be broken. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: it was confirmed the conductor wire insulation was melted. Thermal damage was also observed. The customer stated that there was no loss of cautery due to the reported issue.
 
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Brand NameENDOWRIST
Type of DeviceMARYLAND 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 Key15080685
MDR Text Key296367753
Report Number2955842-2022-13087
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119792
UDI-Public(01)00886874119792(10)K10211004
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471172-16
Device Catalogue Number471172
Device Lot NumberK10211004 0664
Was Device Available for Evaluation? No
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/21/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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