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

Catalog Number CH00000001

Device Problems Defective Component (2292); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that in operating room 3, the chromophare f628 dome cover fell of the light head and hit a nurse on the head, and that the nurse required a visit to the operating room as a result of the incident.No serious injury to the nurse has been reported as a result of this event.This issue reportedly occurred while a patient was in the room, but the patient did not sustain any injuries.The procedure was delayed for an unknown amount of time as the case was moved to a different operating room.A stryker field service technician (sfst) was dispatched to the account to investigate the issue.During the service visit, the sfst confirmed the issue, as he found that the blue center of the dome cover had fallen out.The sfst then proceeded to replace the damaged cover and the issue was resolved.The installation history for the surgical light was reviewed and it was found that the unit was properly installed and passed final qc inspection on (b)(6) 2018.The service history for the suspension was also reviewed, and there were no service tickets found, indicating that the surgical light has not been serviced by stryker personnel since installation.Contact was made with the accounts¿ quality and risk department to gather additional information regarding the injuries sustained by the nurse, but to date, no information has been provided.The root cause of this issue has been identified and was investigated under (b)(4).This investigation is still in progress, and a supplemental report will be filed.

Event Description

It was reported in operating room 3 the f628 dome cover fell off the light head and hit a nurse on the head.The nurse reportedly visited the operating room for treatment.To date no serious injury has been reported.Once the investigation is complete, a supplemental will be filed.

Manufacturer Narrative

It was reported that in or 3, the chromophare f628 dome cover fell of the light head and hit a nurse on the head, and that the nurse required a visit to the or as a result of the incident.The nurse reportedly suffered a concussion significant enough to be considered a serious injury.This issue reportedly occurred while a patient was in the room, but the patient did not sustain any injuries.The procedure was delayed for an unknown amount of time as the case was moved to a different or.A stryker field service technician (sfst) was dispatched to the account to investigate the issue.During the service visit, the sfst confirmed the issue, as he found that the blue center of the dome cover had fallen out.The sfst then proceeded to replace the damaged cover and the issue was resolved.The installation history for the surgical light was reviewed and it was found that the unit was properly installed and passed final qc inspection on 22 october 2018.The service history for the suspension was also reviewed, and there were no service tickets found, indicating that the surgical light has not been serviced by stryker personnel since installation.The root cause of this issue has been identified and was investigated under (b)(4).

Event Description

It was reported in or 3 the f628 dome cover fell off the light head and hit a nurse on the head.The nurse reportedly visited the or for treatment.The nurse reportedly suffered a concussion significant enough to be considered a serious medical injury.

• 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
• MDR Report Key: 8636759
• MDR Text Key: 207494826
• Report Number: 0008010153-2019-00006
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization