MAUDE Adverse Event Report: AESCULAP AG 1/2-SIZE LID W/RETENTION PLATE GOLD; STERILE TECHNOLOGY

Model Number	JK388
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
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 that there was an issue with jk388-1/2-size lid w/retention plate gold.According to the complaint description, it was reported that the device fell.This event/malfunction prolonged the surgery for 15 minutes.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: 1/2-SIZE LID W/RETENTION PLATE GOLD
• Common Device Name: STERILE TECHNOLOGY
• 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: 12787841
• Report Number: 9610612-2021-00720
• Device Sequence Number: 3874356
• Product Code: FLE
• UDI-Device Identifier: 04038653294060
• UDI-Public: 4038653294060
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K792558
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: JK388
• Device Catalogue Number: JK388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown