MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT CAP SINGLE-USE MARKERS; NAVIGATION SYSTEMS AND SUPPORT

Model Number	FS618SU
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 an orthopilot cap single-use markers (part # fs618su) was used during a procedure performed on an unknown date.According to the complainant, there was a lack of visibility of cap markers with opi elite camera (part # fs111).An additional medical intervention was necessary.The complaint device was not returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference xc (b)(4); cc (b)(4).Associated medwatch-reports: 9610612-2021-00402 ((b)(4) fs618su), 9610612-2021-00403 ( (b)(4) fs618su).Involved components: fs111-unknown.
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: ORTHOPILOT CAP SINGLE-USE MARKERS
• Common Device Name: NAVIGATION SYSTEMS AND SUPPORT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11850175
• Report Number: 9610612-2021-00402
• Device Sequence Number: 17121192
• Product Code: HAW
• UDI-Device Identifier: 04046964105289
• UDI-Public: 4046964105289
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013569
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: FS618SU
• Device Catalogue Number: FS618SU
• Device Lot Number: 20915418D3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: FS111-UNKNOWN; FS111-UNKNOWN
• Outcome Attributed to Adverse Event: Other