MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P HANDLE; CLIP, IMPLANTABLE

Model Number	PL520R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a challenger ti-p handle (part # pl520r) was used during a procedure performed on an unknown date.According to the complainant, the pneumatic applier was observed to be broken at the opening.Reportedly, the clip was deflected and failed to clip at the desired location while the patient had arterial bleeding.The complaint device was not available to be returned to the manufacturer for evaluation.No known patient complications were reported as a result of this event.Although requested, additional case and patient information has not been made available.The adverse event is filed under aag reference (b)(4).Concommitant devices: pl536r-unknown, pl520r-62407650.
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: CHALLENGER TI-P HANDLE
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11230872
• Report Number: 9610612-2020-00998
• Device Sequence Number: 3229256
• Product Code: FZP
• UDI-Device Identifier: 04046963313173
• UDI-Public: 4046963313173
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: PL520R
• Device Catalogue Number: PL520R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PL520R-62407650; PL520R-62407650; PL536R-UNKNOWN; PL536R-UNKNOWN