MAUDE Adverse Event Report: AESCULAP AG VALVE XS TC NEEDLEHOLDER STR.225/365MM; SPECIALITIES CARDIO-THORACIC S

Model Number FC275R

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary investigation: the instrument is in used condition, one screw of the handle is missing.Investigation: a pictorial documentation visually and microscopically was carried out.The welded screw lock of one screw is broken and therefore the screw could loosen.The instrument has been forwarded to the manufacturer for further investigations.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: due to the circumstance, that the product has been sent to the manufacturer for investigation, this is a preliminary report and it will be updated after we received a statement from the manufacturer.If additional information is received a follow up report will be submitted.

Event Description

It was reported the screws were loosening intraoperatively.The reporter indicated loosening of the screws on the needle holder occurred during a cardiovascular procedure.The issue was detected during the cleaning process.No additional patient information has been provided.Additional information has been requested, however, not yet received.

• Brand Name: VALVE XS TC NEEDLEHOLDER STR.225/365MM
• Type of Device: SPECIALITIES CARDIO-THORACIC S
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8522721
• MDR Text Key: 142229114
• Report Number: 9610612-2019-00250
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC275R
• Device Catalogue Number: FC275R
• Device Lot Number: 52167761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/05/2019
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1