MAUDE Adverse Event Report: MAQUET CV ULTIMA OPCAB SYSTEM, STANDARD BLADE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-OM-2001S

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima opcab system, standard blade had a mechanical issue and could not be used.The hospital did not report any patient effects.

Manufacturer Narrative

The device was returned to the factory for evaluation.Evidence of blood and clinical use was observed.A visual inspection was performed.The cam and hinge had become misaligned.The device was evaluated for its mechanical function.The device was not able to be assembled onto the reference retractor blade, therefore it could not initially be evaluate for he locking function.The device was further evaluated with the help of engineering.The device, as received, was noted to have remnants of blood and tissue throughout the device, indicating use of the device within a procedure.The lever of the cam was noted to be out of the proper field of rotation.The device was noted to have worn unlocked position notches on the hinge, indicating that the device was locked / unlocked repeatedly during use.When trying to load the device onto a maquet blade reference retractor blade, it required a great deal of force to slide the device onto and off of the reference rail device.Rather, the device should slide smoothly along the blade rail when in the unlocked position.The device as received was in a perpetually locked state.To analyze the received device further, the cam of the received device was cautiously pushed back into the correct position with the hinge, being careful not to damage the parts.Once the cam lever was back in place, the device was able to be slid on to the reference rail and locked into place with no problems observed.A review of the manufacturing process revealed that each device is evaluated for function prior to release which includes loading the device onto a blade component and locked/unlocked prior to packaging.Each unit must meet all specifications and pass inspection prior to release.Based upon the returned condition of the device, the reported complaint for "would not lock on to the rail of the retractor" could not be confirmed.The device is not intended to be disassembled by the user.The complaint device was correctly positioned and functioned as expected.Therefore, there is no indication that a device defect caused or contributed to the event.(b)(4).

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima opcab system, standard blade had a mechanical issue and could not be used.The hospital did not report any patient effects.

• Brand Name: ULTIMA OPCAB SYSTEM, STANDARD BLADE
• 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: 5876649
• MDR Text Key: 52754216
• Report Number: 2242352-2016-00754
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: C-OM-2001S
• Device Lot Number: 25123958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1