MAUDE Adverse Event Report: MAQUET (SUZHOU) CO.,LTD. MAQUET; STABILIZER, HEART

Model Number ACROBAT-I STABILIZER

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer main body of the holder is broken, the operation was completed by replacing with the same equipment, and there's no patient effect, the product is from the lot 3000186224.

Manufacturer Narrative

Trackwise id: (b)(4).The investigation has been started since the complaint was received, the following contents have been conducted: 1.Dhr review: the dhr have been reviewed, there¿s no deficiency identified from production relevant to the acrobat-i stabilizer mount damage prior to this complaint.All the products passed 100% visual and function inspection, which demonstrate the housing mount has no flaws/crack etc.Appearance defect, and all the products were simulate to be fixed on the blade by locking the jaw with no breakage.Raw material (b)(4) was checked and supplier certified that the materials used are conforming to drawing requirement.(b)(4) housing mount supplier dhr was checked, and the injection parameter and product inspection was found normal and no non-conformity observed.(b)(4).3.Randomly checked 800 ea (b)(4) housing mount from another lot 3000173023, there's no flaws/crack etc.Appearance defect observed.The radius on the housing mount has also been checked, the radius is conforming to the drawing requirement.4.Device was received on mar.7th, below evaluations were conducted: 1) visual inspection there¿s no obvious cosmetic defects found on the housing mount, and the fracture did not appear to have propagated along a knit line, flow mark or parting line.Which is same with the hospital feedback, there¿s no visual appearance defect on the mount part.2) the dimension of the fractured chips and 15ea housing mount from batch#:3000207418 was measured, the dimensions are within drawing specification and no abnormal was found.3) simulation test to follow labeling instruction of using regarding mount and dismount test on maquet retractor was performed for two devices from same lot.The device was hooked on the retractor, then locking the lever and tighten the knob and link arm.Repeat the test for 30 times, and check the physical of the mount between each test.The test result indicated no any mount damage or fracture observed, which indicated no fracture risk under normal using.4) fracture simulation test was performed from a random lot without this complaint.To make the housing mount be fractured need to apply extreme strength even put the weight of the body on it, which indicated no housing mount fracture risk under normal using.5) fracture force and locking force was studied with 15 ea (b)(4) housing mount from lot 3000100036.It¿s indicated that the jaw locking force is around 285 n and with 1 ppm chance would reach 324 n.The breakage force mean is about 747 n and with 1 ppm chance the breakage force be lower to 457 n.Further capability of jaw locking force was studied as well, and no probability to result in the mount anterior portion fracture in normal use was observed.Based on above investigation, no physical or dimension deficiency indicating or contribute to the report failure was found on the reported device; the supplier certified that material meet drawing requirements.The simulation mount and dismount test follow labeling instruction did not indicate any failure.Fracture simulation test indicated extreme strength is needed to break the housing mount.Detail fracture force study also indicated no probability to result in the mount anterior portion fracture in normal use.The event occurred during the use of the device and the procedural operation is unavailable for our review.With the available information, it is not possible to determine if the device was used in accordance with the labeling in regards to the reported failure.The most probable root cause of the anterior portion fracture would be much force used during adjusting the stabilizer or the anterior portion was fixed during removing the stabilizer from the retractor.

• Brand Name: MAQUET
• Type of Device: STABILIZER, HEART
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• Manufacturer (Section G): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• Manufacturer Contact: lu helena ; no.158 fang zhou road; suzhou industrial park; suzhou
• MDR Report Key: 13866088
• MDR Text Key: 296804716
• Report Number: 3007417753-2022-00010
• Device Sequence Number: 1
• Product Code: MWS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: ACROBAT-I STABILIZER
• Device Catalogue Number: C-OM-10000
• Device Lot Number: 3000186224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: Asian