MAUDE Adverse Event Report: AESCULAP AG ATR.VASCULAR CLIP 25MM CVD.3.43N ARTERI.; CLAMP, VASCULAR

Model Number	PL548S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2021
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 (b)(4) that a atr.Vascular clip 25mm cvd.3.43n arteri.(part # pl548s) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, the patient suddenly dropped out while grasping the blood vessel with the device.Due to the occurrence of this event, the patient was transferred to open surgery.There was no infection and no health hazard to patient reported.No information was provided as to a specific device malfunction.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.Investigation was carried out by q-coordinator of the production plant.No production related trouble found.The error described could be usage related.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures based on the investigation of the production plant, a production related error can be excluded.The closing force test as well as the water bag test was passed.A usage related error cannot be excluded.Based upon the investigations results a capa is not necessary.

• Brand Name: ATR.VASCULAR CLIP 25MM CVD.3.43N ARTERI.
• Common Device Name: CLAMP, VASCULAR
• 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: 11518654
• Report Number: 9610612-2021-00179
• Device Sequence Number: 19752507
• Product Code: DXC
• UDI-Device Identifier: 04046963094089
• UDI-Public: 4046963094089
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992053
• 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): 12/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: PL548S
• Device Catalogue Number: PL548S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown