MAUDE Adverse Event Report: AESCULAP AG PAEDISCOPE EYEPIECE; NEUROENDOSCOPY

Model Number	PF011A
Medical Device Problem Codes	Mechanical Problem (1384); Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
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 that there was an issue with pf010a-paediscope flexible scope.According to the complaint description,during cyst fenestration procedure there was an surgery delay due to that very poor or no image came through the scope.Light source appeared to be fully operational.However, when scope was attached to the camera, there was no visable image.The image that came through was dark, and surgeon was not able to proceed with the case.The patient was under anesthesia.Incident caused surgeon to stop the case and reschedule for another procedural date.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Event or Problem Description
The article code of the device changed to pf011a - paediscope eyepiece and due to additional information received the patient harm changed to surgery delay.
Additional Manufacturer Narrative
Investigation results: visual investigation: product was directly forwarded to the manufacturer for investigation.Exerpt of the analysis by manufacturer: " the technical analysis could not detect any error.No defect can be detected on the eyepiece.Only signs of use could be found, whidch are due to the use of the instrument.Due to the age of the eyepiece it is recommended to replace the sealing element and clean the eyepiece lens system." batch history review: review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results there is no indication for a material-, manufacturing- or design-related failure.No failure was detected during investigation.Based upon the investigations results a capa is not necessary.

• Brand Name: PAEDISCOPE EYEPIECE
• Common Device Name: NEUROENDOSCOPY
• 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: 12536365
• Report Number: 9610612-2021-00637
• Device Sequence Number: 16461564
• Product Code: GWG
• UDI-Device Identifier: 04038653320547
• UDI-Public: 4038653320547
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K014149
• 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): 02/16/2022

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: PF011A
• Device Catalogue Number: PF011A
• Device Lot Number: B020321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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