MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P HANDLE; LIGATION / VESSEL CLIPS

Model Number	PL520R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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 inc.That a challenger ti-p handle (part # pl520r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the cartridge container fell into the patient's cavity intraoperatively.The complaint device was 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).Involved components: pl536r - shaft compl.D:10mm l:370mm - lot unknown.
Event or Problem Description
Update: after investigation results were reviewed, the products were confirmed.Involved components pl520r - challenger ti-p handle (9610612-2021-00613) (b)(4).Associated medwatch reports: pl536r - shaft compl.D:10mm l:370mm (9610612-2022-00307) (b)(4).
Additional Manufacturer Narrative
Correction: b5: based on the investigation results, the leading material and involved component were updated.Investigation: visual investigation: here we detected that the shaft gets a third-party maintenance service, and based on that we can no longer guarantee the specifications of the product.The jaws of the shaft are misaligned.Furthermore, the products have been forwarded to the responsible production department for further analysis.Findings: the stock is generally in very poor condition, the jaws are badly misaligned, the stop plate is torn off on one side, the root protrusion in the clip guide is damaged.The handle is fully functional.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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably third party maintenance/repair-related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results a capa is not necessary.

• Brand Name: CHALLENGER TI-P HANDLE
• Common Device Name: LIGATION / VESSEL CLIPS
• 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: 12424145
• Report Number: 9610612-2021-00613
• Device Sequence Number: 4648949
• Product Code: FZP
• UDI-Device Identifier: 04046963313173
• UDI-Public: 4046963313173
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081031
• 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): 10/28/2022

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: PL520R
• Device Catalogue Number: PL520R
• Device Lot Number: 62428912
• 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: 08/12/2021
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PL536R - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown