MAUDE Adverse Event Report: AESCULAP AG TC METZ WVCT SCISSBRD-BLDCVD230MM; BASIC INSTRUMENTS

Model Number	BC287W
Medical Device Problem Codes	Product Quality Problem (1506); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with bc287w - tc metz wvct scissbrd-bldcvd230mm.According to the complaint description, the scissors doesn¿t cut during surgery.The instrument was used for toracovascular surgery.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: a visual inspection of the product was made.A slightly damaged cutting edge was found.Furthermore the product was sent to the production department for further investigation.The report will be updated when we received a statement from the production department.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.If the review shows any conspicuity, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results/ visual investigation: the investigation was carried out visually and microscopically with the digital microscope.Furthermore the product was sent to the production department for further investigation.Based on the feedback of the subject expert ( "scissors do not cut.The product does not fulfill its function).On the lock we observe looseness and the screw is loose.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: upon the investigation results we assume that the root cause for the problem is most probably usage related.Based upon the investigations results a capa is not necessary.

• Brand Name: TC METZ WVCT SCISSBRD-BLDCVD230MM
• Common Device Name: BASIC INSTRUMENTS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11653154
• Report Number: 9610612-2021-00302
• Device Sequence Number: 17018901
• Product Code: LRW
• UDI-Device Identifier: 04038653138067
• UDI-Public: 4038653138067
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: BC287W
• Device Catalogue Number: BC287W
• Device Lot Number: 51636601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 10/29/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 08/26/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown