MAUDE Adverse Event Report: MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-UA-5001

Device Problems Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

It was reported by customer their newly ordered ua-5001 arrived without a handle.Original order was (b)(6) 2017.No patient involvement, device never made it out of shipping / biomed.Picture is attached in this report.

Manufacturer Narrative

(b)(4).Trackwise number # (b)(4).Autonumber # (b)(4).

Event Description

It was reported by customer their newly ordered ua-5001 arrived without a handle.Original order was 4/7/2017.No patient involvement, device never made it out of shipping / biomed.Picture is attached in this report.

Manufacturer Narrative

(b)(4).Internal complaint number: (b)(4).Autonumber: # (b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection determined that the drive handle was detached and missing from the activator ii drive mechanism.No other visual defects were observed.Based on the returned condition of the device the reported complaint for the reported failure mode was confirmed for ¿component missing.¿ the shop floor paperwork was reviewed for the activator ii drive mechanism.All the test results meet the specifications and results.There were no non-conformities observed.The shop floor paper work is available for review as attachments.The certificate of conformance was reviewed for component missing.The vendors certify that all the device lots manufactured conforms to all the applicable product specifications.There were no non-conformities observed in the device lot.

Event Description

It was reported by customer their newly ordered ua-5001 arrived without a handle.Original order was 4/7/2017.No patient involvement, device never made it out of shipping / biomed.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6558936
• MDR Text Key: 75008816
• Report Number: 2242352-2017-00473
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-UA-5001
• Device Lot Number: 25130707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1