MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG F-GEN TOUCH WALL CONTROL, VER 2; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number P37633

Device Problem Crack (1135)

Patient Problem Eye Injury (1845)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that the wall control was not working, and that the biomed was instructed to reseat the cables behind the wall control.During this process, the glass on the wall control reportedly shattered causing injury near the eye.The biomed was sent to the er for further evaluation.The account provided photos which showed that the glass face of the touch control device had cracks that spanned across the entire width and height of the device.There was one spot at the bottom of the face glass where a shard of glass appeared to have broken off.Contact has been made with the account to determine if they would like a stryker field service technician to go onsite and investigate, but to date, no reply has been received.Although the exact root cause of this issue is unknown, based on the photos provided, the most likely root cause would be collision of the device with the floor or other equipment in the room due to inadvertent dropping or mishandling by the user.This issue has not exceeded any thresholds and will continue to be monitored per (b)(4).The investigation is still in progress.If further information is obtained a supplemental will be filed.

Event Description

It was reported that an f-gen surgical light was broken.The wall control was not working.The biomed was instructed to reseat the cables behind the wall control.The glass shattered when he was trying to do that and biomed was injured near his eye and went to the er.

Event Description

It was reported that an f-gen surgical light was broken.The wall control was not working.The biomed was instructed to reseat the cables behind the wall control.The glass shattered when he was trying to do that and biomed was injured near his eye and went to the er.

Manufacturer Narrative

It was reported by sales rep that the wall control was not working.Sales rep instructed the biomed to reseat the cables behind the wall control.The glass shattered when he was trying to do that and biomed was injured near his eye and went to the er.Upon further investigation it was found that the customer had a brownout and no longer had power at the wall control.In order to troubleshoot biomed tried to reseat the cables behind the wall control and in process of removing the wall control potentially due to excessive force or wrong method glass was broken and hit the biomed.This failure mode is captured in risk file rsk12227 with severity of s3 and this instance does not affect the risk file.Cause of this issue is brown out at customer end and handling by untrained biomed.If any further information is obtained, a supplemental will be filed.H3 other text: 81.

• Brand Name: F-GEN TOUCH WALL CONTROL, VER 2
• 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: 16801385
• MDR Text Key: 313906999
• Report Number: 0008010153-2023-00011
• Device Sequence Number: 1
• Product Code: FSY
• 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: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P37633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• 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
• Patient Outcome(s): Other