MAUDE Adverse Event Report: AESCULAP AG MACRO DISP.GRASP.FCPS.BIPOLAR 5/310MM; BIPOLAR DISPOSABLE INSTRUMENTS

Model Number	PL703SU
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
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 reported to aesculap aag that macro disp.Grasp.Fcps.Bipolar 5/310mm (part # pl703su) was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2021.According to the complainant during, the procedure, the branch of the pincers fell into patient's abdomen.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results visual investigation vigilance investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.It was not possible to carry out a functional test, probably during thermal processing, the components of both forceps have been deformed.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based on the investigation, the material of the jaw was not sufficiently hardened.Presumably this was conducive to the fracture of the jaw.A product safety case will be requested.Any action regarding capa will be addressed with this case.

• Brand Name: MACRO DISP.GRASP.FCPS.BIPOLAR 5/310MM
• Common Device Name: BIPOLAR DISPOSABLE 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: 12104617
• Report Number: 9610612-2021-00467
• Device Sequence Number: 19876225
• Product Code: GCJ
• UDI-Device Identifier: 04046963398804
• UDI-Public: 4046963398804
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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 Expiration Date: 11/24/2025
• Device Model Number: PL703SU
• Device Catalogue Number: PL703SU
• Device Lot Number: 52651642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 89 YR
• Patient Sex: Unknown