MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number CH00000001

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that in operating room 22, the d series light disconnected from the spring arm.No patient involvement was reported.A stryker field service technician (sfst) was dispatched for investigation.The sfst confirmed that the light had been removed and taken out of service prior to his arrival.During his inspection, the sfst found that four mounting screws which are used to secure the cardanic arm to the surgical light had backed out.Onsite investigation photos were provided that showed damage to the cardanic arm threads and the screws.It was also noted that there was a sticker on the surgical light that indicated the last preventative maintenance was completed in november 2018 by the hospital clinical engineering team.Repairs are currently pending.Both the service and installation history for the surgical light system were reviewed.The service ticket database showed that there were 4 previous service tickets opened for the surgical light suspension.All 4 of these service cases were opened back in year 2010.Three of these cases reported issues pertaining to the in light camera, and one of the cases involved a reported issue with surgical light drifting.There were no reports of repairs or adjustments made to the cardanic arm in any of these service cases.The most recent of these four cases was opened back on 11 june 2010, indicating that the surgical light has not been serviced by stryker personnel since that date.The installation history was reviewed, and it was found that the light was installed on or around 30 june 2008 and has been in use for over 10 years.Based on the physical evidence, the installation history, and the service history, the root cause of cardanic arm separation would be loosening of the cardanic arm hardware due to improper maintenance by hospital personnel.As was reported, this issue was discovered outside of procedure, and there was no reported injury or adverse event.

Event Description

It was reported in or 22 light that came disconnected from spring arm.There was no reported patient involvement or adverse consequences.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; 74611810
• MDR Report Key: 8578445
• MDR Text Key: 161280018
• Report Number: 0008010153-2019-00005
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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