MAUDE Adverse Event Report: AESCULAP AG OCHSNER-DE'BAKEY ATR.AORTA CLMP 230MM; CLAMP

Model Number	FB495R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem Description
It was reported to aesculap ag that two (2) ochsner-de'bakey atr.Aorta clmp 230mm devices (part # fb495r) (ref.Associated mdr id 9610612-2020-00444) were used during an unknown surgical procedure.According to the complainant, while using the clamps, there was no complete occlusion of the blood flow, and the patient continued to bleed.This created difficulty for the surgeon, who noted the possibility of this being a life threatening situation.The user stated that there appeared to be differences in the amount of light that passed through the closed jaws from one clamp to the next.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00444.
Additional Manufacturer Narrative
Investigation results: 5 clamps were available for investigation.Visual investigation: the provided clamps are in a good condition, no deviations can be found.Clamp 1, 2 and 3 are used, clamp 4 and 5 have been provided in the original packaging.Clamp1: the jaw surface is not closing completely.Clamp 2 and 3: are in a good condition.Clamp 4 and 5: there can be found burrs at the serration of clam.Batch history review: the device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.Risk evaluation: the current failure rate is within the risk analysis and therefore acceptable.Conclusion and root cause description: clamp 2 and 3: n/a.Clamp: 1, 4 and 5: the root cause of the problem is most probably manufacturing-related.First complaint, for this product record, no systematically failure.The trend analysis did not show any complaints.Preventive measures: the q-coordinator of the production plant will be informed about the found deviations.
Event or Problem Description
Associated medwatch-reports: 9610612-2020-00444 (400482527 - fb495r - quantity: 3).

• Brand Name: OCHSNER-DE'BAKEY ATR.AORTA CLMP 230MM
• Common Device Name: CLAMP
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10554714
• Report Number: 9610612-2020-00511
• Device Sequence Number: 14055922
• Product Code: HXD
• UDI-Device Identifier: 04038653156429
• UDI-Public: 4038653156429
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB495R
• Device Catalogue Number: FB495R
• Device Lot Number: 4508969258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening