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

Model Number POINTER PROBE

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer owns two pointers, and the non sterile one did not pass the accuracy check.

Manufacturer Narrative

It was reported that on (b)(6) 2019, the company representative noted during a preventative maintenance that the non sterile pointer probe s/n (b)(6) did not pass the accuracy check.The event described in the complaint was confirmed by our analysis : the pointer probe s/n (b)(6) needs to be recalibrated.At this point, the part has not been returned to the manufacturing site for recalibration.Based on the investigation performed, the technical root cause of the event was determined to be that the pointer probe is out of calibration.Pointer probes should be manipulated carefully to preserve their calibration.The most probable root cause would be a shock or drop of the pointer probe, or a normal wear of the pointer probe, that altered its calibration.However the exact root cause cannot be determined.

Event Description

The customer owns two pointers, and the non sterile one did not pass the accuracy check.

• 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: 9391542
• MDR Text Key: 193945547
• Report Number: 3009185973-2019-00422
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: POINTER PROBE
• Device Catalogue Number: POINTER PROBE
• Device Lot Number: ROSA-034B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1