MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PROGRASP FORCEPS

Model Number 470093-10

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the device involved with the complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The instrument was found to have the distal pin dislodged from its normal position.A further investigation found that the dislodged clevis pin was likely due to an incomplete swage.The swaging operation is performed during assembly and it is possible that this instrument did not get properly swaged (workmanship issue).Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.The customer reported complaint does not itself constitute an mdr reportable event; however; the dislodged clevis pin found during failure analysis evaluation could cause or contribute to an adverse event if the failure mode to recur.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, a pin on the prograsp forceps instrument broke.Therefore, the instrument could not be removed from the cannula and damaged the cannula.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: it was confirmed that no fragments fell inside the patient and the procedure was completed without patient harm, adverse outcome or injury was reported.

• Brand Name: ENDOWRIST
• Type of Device: PROGRASP FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7585228
• MDR Text Key: 110575774
• Report Number: 2955842-2018-10276
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112267
• UDI-Public: (01)00886874112267(10)N10180112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470093-10
• Device Lot Number: N10180112 99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1