MAUDE Adverse Event Report: AESCULAP AG CRILE FORCEPS CVD 140MM; HAEMOSTATIC FORCEPS

Model Number	BH145R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a crile forceps cvd 140mm (part# bh145r) was used during a cesarean procedure on (b)(6) 2023.According to the complainant the device had broke during the procedure.The fragment was able to be retreived and an x-ray was performed on the patient.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
Additional information: the investigation was updated and review of the photograph was included.Investigation results: as of the date of this report the complaint product was not provided for investigation.A photo was provided and examined ; the broken jaw can be recognized.Device history review: the device quality and manufacturing history records 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.Review of device history showed there are two (2) other similar complaints within this batch.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The assessment for the reportability of this adverse event was based on patient harm, additional medical intervention.Conclusion/preventive measures: based upon the above mentioned investigation results, a definitive root cause could not be established.The reported damage of the product was confirmed via photo.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.

• Brand Name: CRILE FORCEPS CVD 140MM
• Common Device Name: HAEMOSTATIC FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18291816
• Report Number: 2916714-2023-00122
• Device Sequence Number: 6668117
• Product Code: HRQ
• UDI-Device Identifier: 04038653025800
• UDI-Public: 4038653025800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024
• Report Date (Section F): 12/08/2023

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: BH145R
• Device Lot Number: 4509387361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2023
• Device Age: 69 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/31/2024
• 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: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 12/08/2023