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

Model Number CH00000001

Device Problem Material Separation (1562)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported by a nurse that a blue dome cover has fully separated.There were no reported injuries or adverse consequences.

Manufacturer Narrative

It was reported that the blue dome cover separated from the f generation light.There was no patient involvement, no injuries, no adverse consequences or delay.Per rsk12227 revision v, the severity is s0.The exact root cause for the dome separation is unknown and return of the product to stryker is pending.Once further information is obtained, a supplemental will be filed.

Event Description

It was reported by a nurse that a blue dome cover has fully separated.There were no reported injuries or adverse consequences.

Manufacturer Narrative

Nurse emailed in blue dome cover has fully separated salesforce case number (b)(4).As reported this issue was observed during morning cleaning setup.Picture provided confirms the issue of separation.Dhr of the affected product was reviewed and it evident that it passed inspection at the time of manufacturing.This is an old light head which was manufactured in year 2014.Manual 700000335 has proper instructions to replace the covers.Potential cause of this issue could be normal wear and tear due to age of the product.There was no patient involvement or adverse consequence reported.If further information is obtained a supplemental will be filed.H3 other text : 81.

• 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 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 16911687
• MDR Text Key: 315006123
• Report Number: 0008010153-2023-00012
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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: Other
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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