MAUDE Adverse Event Report: AESCULAP AG DE'BAKEY ATR.FCPS 1.5MM STR150MM; BASIC INSTRUMENTS

Model Number	FB411R
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with fb411r - de'bakey atr.Fcps 1.5mm str150mm.According to the complaint description, the device once tore tissue during a hernia procedure.It was noted that the "teeth" did not approximate correctly.A temporary impairment occurred; there was no further patient harm nor surgical delay.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Additional Manufacturer Narrative
Investigation: the instruments were tested according to qstd.The test material (silk paper) is not damaged when the tweezers are closed evenly.The inner sides of the jaw tips are rounded according to the specifications and do not hook into the skin during the tactile test.The jaw closes resiliently from the jaw tip over the entire interlocking tooth profile.Device history record: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Explanation and rationale/conclusion: no deviations from the specifications valid at the time of production could be ascertained.Maybe twisting of the forceps legs may have led to tearing of the tissue.No product related failure could be detected.Based upon the investigation results, a capa is not required.

• Brand Name: DE'BAKEY ATR.FCPS 1.5MM STR150MM
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16913152
• Report Number: 9610612-2023-00090
• Device Sequence Number: 6527277
• Product Code: HTD
• UDI-Device Identifier: 04038653043279
• UDI-Public: 4038653043279
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/07/2023

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: FB411R
• Device Catalogue Number: FB411R
• Device Lot Number: 4513416707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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