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

Model Number JK388

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event 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).

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
• Type of Device: 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
• MDR Text Key: 280599751
• Report Number: 9610612-2021-00720
• Device Sequence Number: 1
• Product Code: FLE
• UDI-Device Identifier: 04038653294060
• UDI-Public: 4038653294060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK388
• Device Catalogue Number: JK388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1