MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG EXAMINATION LIGHT F 300 MOBILE, LED, DIMMABLE, 100-120 V(AC) WITH SWITCHING POWE; AC-POWERED MEDICAL EXAMINATION LIGHT

Catalog Number CF 2893059

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the f300 light allegedly would not power on.A stryker field service technician (sfst) was dispatched to the customer site.During the investigation it was found that the c-clip was out of place, causing a gap.The sfst removed and then reinstalled the c-clip.After the sfst verified that the light was fully functional, the light was released back to full use.The investigation into the c-clip being out of place is ongoing.There was no patient involvement and no adverse event reported to have occurred.

Event Description

It was reported that the light allegedly would not power on.There was no patient involvement and no adverse event reported to have occurred.

Manufacturer Narrative

The date the issue first occurred as well as the awareness date of a stryker employee were both (b)(6) 2017.The manual entry on the record was mistyped to state (b)(6) 2016.

Event Description

It was reported that the light allegedly would not power on.There was no patient involvement and no adverse event reported to have occurred.

Manufacturer Narrative

It was reported that the f300 light allegedly would not power on.Further investigation was completed indicating that when the light was installed, it passed checks for functionality and did not have any gaps per the quality inspection procedure (qip).This would indicate the c-clip was properly seated at installation.There have been no service activities performed by stryker since installation.It is possible that modifications have been made to this product on site by non-stryker representatives, but root cause cannot be confirmed.

Event Description

It was reported that the light allegedly would not power on.There was no patient involvement and no adverse event reported to have occurred.

• Brand Name: EXAMINATION LIGHT F 300 MOBILE, LED, DIMMABLE, 100-120 V(AC) WITH SWITCHING POWE
• Type of Device: AC-POWERED MEDICAL EXAMINATION LIGHT
• 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: 6352615
• MDR Text Key: 68130982
• Report Number: 0008010153-2017-00013
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CF 2893059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• 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