MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG SPRING ARM AC 12-20 KG 7 POLE; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number 106632

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the chromophare light head fell off the suspension onto the surgical table.This happened in the evening and the housecleaning crew found the light head on the table.There seems to be no damage to the light head itself.There were no reported injuries or adverse consequences and no patient involvement.

Event Description

It was reported that the chromophare light head fell off the suspension onto the surgical table.This happened in the evening and the housecleaning crew found the light head on the table.There seems to be no damage to the light head itself.There were no reported injuries or adverse consequences and no patient involvement.

Manufacturer Narrative

The product was identified as a spring arm ac, 12-20 kg, 7 pole, part #106632.The reported serial number for the device is (b)(6).The product was inspected by the field service technician (fst) via a customer site visit.During a phone interview with the fst on (b)(6) 2024, he informed that it was reported that the cleaning crew was cleaning the light, and while she was turning it around, the light head fell on the surgical table.According to the fst, when he arrived at the site, the spring arm was all the way up (no tension) and the c-clip (retainer) and a screw were missing.He estimates the installation was completed about 3 years ago.According to his knowledge, the account has 1 biomed staff.The fst reported that when he noticed the missing screw and c-clip, he serviced the unit by replacing those components and put it back into service.The manufacturing dhr for the spring arm was reviewed.The document shows all passing results for all criteria (including mechanical function and cycle test).Qip was completed on (b)(6)2021 for this asset.Although the exact root cause of this issue is unknown, based on the information reported the issue would be attributed to a maintenance issue but exact root cause cannot be established.As reported, there was no patient involvement or adverse event.This failure mode has not exceeded any thresholds and will continue to be monitored per (b)(4).If further information is obtained a supplemental will be filed.

• Brand Name: SPRING ARM AC 12-20 KG 7 POLE
• 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: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18839745
• MDR Text Key: 337800298
• Report Number: 0008010153-2024-00004
• 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: 05/03/2024

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 Catalogue Number: 106632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 05/03/2024
• 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