MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION / VESSEL CLIPS

Model Number	PL569T
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap ag that a ligating clips m/l 12/box (part # pl569t) was used during a procedure performed on an unknown date.According to the complainant, the patient verbally contacted toronto humane society (ths) with regards to product.It was potentially used during a procedure in (b)(6) 2015.Patient reported feeling unwell since this time.Patient has requested further information with regards to the manufacturer/composition of product in order to proceed with further testing through his/her physician.Ths has not received a complaint from the hospital with regards the product.Patient harm was unknown.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: h6 - codes updated.Investigation results: visual investigation: the complaint sample was not provided for investigation, thus a failure description is not possible.No investigation method could be applied, because we didn't received the product.Batch history review: due to the fact that no lot number was provided for the leading material, a review of the device history records as well as a batch-related complaint history review is not possible.Explanation and rationale: without the complaint sample available for investigation, we cannot determine an exact conclusion and root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can be excluded.The ligature clips are made of pure titanium according to iso 5832-2.According to the instruction for use, the usage of the products is contra-indicated in case of foreign body sensitivity for titanium.If further investigations are required, the product should be provided for examination.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.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16507189
• Report Number: 9610612-2023-00039
• Device Sequence Number: 11601003
• Product Code: FZP
• UDI-Device Identifier: 04038653341375
• UDI-Public: 4038653341375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: PL569T
• Device Catalogue Number: PL569T
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown