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

Model Number	BH145R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was to aesculap ag that a crile forceps cvd 140mm (part # bh145r) was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the crile forceps broke which caused a catheter to slip and effected the surgery.The complaint device has been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00726 (400533509 bh145r), 9610612-2021-00727 (400533511 bh145r), 9610612-2021-00728 (400533513 bh145r), 9610612-2021-00687 (400530950 bh145r).
Event or Problem Description
This case is not associated with the listed medwatch reports below.Associated medwatch-reports: 9610612-2021-00726 (400533509 bh145r), 9610612-2021-00727 (400533511 bh145r), 9610612-2021-00728 (400533513 bh145r), 9610612-2021-00687 (400530950 bh145r).It is possibly associated with (b)(4).
Additional Manufacturer Narrative
Updated b3: date of event based upon updated product risk analysis, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
Event or Problem Description
This case is not associated with the listed medwatch reports below.Associated medwatch-reports: 9610612-2021-00726 (400533509 bh145r) 9610612-2021-00727 (400533511 bh145r) 9610612-2021-00728 (400533513 bh145r) 9610612-2021-00687 (400530950 bh145r) it is possibly associated with 400529799.

• Brand Name: CRILE FORCEPS CVD 140MM
• Common Device Name: HEMOSTAT
• 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: 12747459
• Report Number: 9610612-2021-00687
• Device Sequence Number: 11979168
• Product Code: HRQ
• UDI-Device Identifier: 04038653025800
• UDI-Public: 4038653025800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022

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: BH145R
• Device Catalogue Number: BH145R
• Device Lot Number: 4509387361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 10/06/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/02/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2018
• 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