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

Catalog Number CH00000001

Device Problems Component Missing (2306); Separation Problem (4043)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that in operating room 7, there was a chromophare light that has become loose and appeared ready to fall from the spring arm.A stryker field service technician (sfst) was dispatched for investigation.When the sfst arrived at the account, he found that the surgical light had already been removed by hospital staff, but he was unable to locate the light or the mounting hardware.The sfst revisited the account 3 days later to reinstall the light.The technician noted that the account did not provide the original safety segment hardware, so he proceeded with the reinstallation by using safety segment hardware from his mobile inventory.After ensuring the light was properly secured to the spring arm, a functional test was performed, and the equipment was found to be working to specification.The equipment was then returned back to service and the issue was resolved.The sfst interviewed the hospital staff to determine how the keeper clip became missing.None of the hospital staff knew how the issue happened or if another vendor had been performing maintenance on the equipment.The installation history for the surgical light system was reviewed and it was found that the unit was installed on (b)(6) 2018.The service history for the suspension was also reviewed, and there were no service tickets found, indicating that the suspension has not been serviced by stryker personnel since installation.Although the exact root cause of this issue is unknown, the most likely root cause would be improper service and maintenance by hospital personnel.There was no injury or adverse event reported.

Event Description

It was reported a chromophare light has became loose and appeared to be ready to fall off the arm.There was no patient involvement or adverse consequences reported from the event.

• 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: 8506600
• MDR Text Key: 151928254
• Report Number: 0008010153-2019-00003
• 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: 04/11/2019

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
• Device Operator: No Information
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/11/2019
• 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