MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA CEILING CLADDING D144; POLARIS AND SU CEILING CLADDING, BALDACHIN, COVER

Catalog Number G19221

Device Problem Material Disintegration (1177)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that a screw as part of the ceiling installation had fallen into the surgical field.There were no patient health consequences reported.

Event Description

It was reported that a screw as part of the ceiling installation had fallen into the surgical field.There were no patient health consequences reported.

Manufacturer Narrative

The investigation was based on the available information including pictures.Affected parts had been requested for inspection but could not be made available.Based on the investigation the reported issue of loose screws and a loose ceiling cladding could be verified.It was not possible to finally identify the root cause of the current issue.Potential root causes are incomplete tightening of the screw during installation (2021) or the self-tapping screw might have damaged the holding plate due to screwing-in the screw several times with higher force, so that the screw was no longer tight.Operating the device might have also contributed to the reported issue, as positioning the product can lead to small forces which are transferred to the ceiling cladding and its connections and which can cause further loosening of an already loose screw.The correct installation of the ceiling cladding is described in the assembly instructions.According to the instructions for use, the proper operation of the system must be checked before each use, including a visual inspection.Since the sheet metal ceiling cladding construction was introduced in 2003, this is the only known case of a sheet metal screw (3.9 x 16) falling out of the ceiling cladding and into the surgical field; no other similar issues were reported.The number of similar cases, related to the same root cause, is therefore within the expected range of the respective risk assessment and thus accepted.

• Brand Name: CEILING CLADDING D144
• Type of Device: POLARIS AND SU CEILING CLADDING, BALDACHIN, COVER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 13202923
• MDR Text Key: 285808611
• Report Number: 9611500-2022-00008
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• PMA/PMN Number: D167937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G19221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: NA.; NA.