MAUDE Adverse Event Report: MEDTECH SA ROSA SURGICAL DEVICE; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number DRILL ADAPTOR

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

It was reported that during a surgery, while resident was drilling the hole for the first trajectory, the drill bit became stuck in the 2.45 drill adaptor.Field service engineer recommended removing the adaptor from the instrument holder and replacing with the second 2.45 drill adaptor in the tray.Circulating nurse located a new drill bit, and surgery proceeded.

Manufacturer Narrative

Both drill adaptors available on site were analyzed as it is not possible to determine which one was used during the subject surgery.Visual inspection showed that the two drill adaptors are conform and no visual damage is visible.The complaint description states that a resident was drilling when the drill bit became stuck in the drill adaptor.It is not possible to know if the resident is well trained on rosa device but a probable cause of the event may be that the resident is a novice and not used to perform a surgery with rosa.

• Brand Name: ROSA SURGICAL DEVICE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 7360989
• MDR Text Key: 103292063
• Report Number: 3009185973-2018-00096
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRILL ADAPTOR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1