MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FEN.5/310MM; HANDHELD PRODUCTS & LIGATION

Model Number	PM438R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2021
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 ag that a jaw ins.Bip.Maryland diss.Fen.5/310mm (part # pm438r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the tip of the forceps was broken.A foreign substance of about 3 mm was confirmed by x-ray photography after the surgery.Therefore, when the bipolar tip was confirmed, the ceramic part was broken.The complaint device has not yet been returned to the manufacturer for evaluation.The fragment remained in situ.Although requested, additional information has not been made available.The malfunction is filed under (b)(4).Involved components: pm973r - insulated outer tube 5/5mm 310mm - lot unknown.Pm450r - handle for bipolar instruments - lot unknown.
Additional Manufacturer Narrative
Additonal information received related to patient harm.The patient harm changed to additional medical intervention as an x- ray was necessary.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.Explanation and rationale: if further investigations are required, the product should be provided for examination.The insulation is made of ceramic.In all related articles, an average of 27.4 similar fracture-related cases occurred per year.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based on the investigation results, a capa is not necessary.
Event or Problem Description
Involved components.Pm973r - insulated outer tube 5/5mm 310mm - lot unknown.Pm450r - handle for bipolar instruments - lot unknown.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• 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: 13027644
• Report Number: 9610612-2021-00759
• Device Sequence Number: 11974011
• Product Code: GEI
• UDI-Device Identifier: 04038653322862
• UDI-Public: 4038653322862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001330
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2022

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: PM438R
• Device Catalogue Number: PM438R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 11/03/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/03/2022; 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PM450R - HANDLE FOR BIPOLAR INSTRUMENTS -; PM450R - LOT UNKNOWN; PM973R - INSULATED OUTER TUBE 5/5MM 310MM -; PM973R - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown