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

Model Number COMPUTER FOR PRE OP PLANNING

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

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

During the planning of the case, the field service engineer and surgeon tried to load the pet.It was checked that all required image-tags are set.Everything was good.The pet was loaded , but it was reported that they only saw2 mostly blue lines.The import was skipped, since the image was not necessary for the case.

Event Description

During the planning of the case, the field service engineer and surgeon tried to load the pet.It was checked that all required image-tags are set.Everything was good.The pet was loaded , but it was reported that they only saw2 mostly blue lines.The import was skipped, since the image was not necessary for the case.

Manufacturer Narrative

It was reported that the loading of the pet was not possible.Event summary, device history record review and complaint history review did not identify contributing factors.The investigation indicated that the pet scan was not readable by the device because the number of slices it contained was inferior to the limit recommended by the ifu.

• 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; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 7845182
• MDR Text Key: 119157988
• Report Number: 3009185973-2018-00236
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMPUTER FOR PRE OP PLANNING
• Device Catalogue Number: ROSAS00349
• Device Lot Number: 2.5.8.4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1