MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS PKG, VISUM LED 2 SURGICAL LIGHT, CAMERA READY; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 0682001253

Device Problem Separation Failure (2547)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that in or 7 the visum ll light head had allegedly come off the spring arm.The field service technician (fst) investigated and found that the light had separated from the cardanic arm and not the spring arm as was originally reported.Further investigation revealed that the circlip that is used to secure the cardanic arm to the light head was missing.A quote for a replacement light head was provided to the customer and purchase is pending.Potential reasons for the missing circlip include improper maintenance by the hospital, as the site does perform some maintenance themselves, or improper assembly during the manufacturing process.There was no patient involvement or adverse consequence reported.The investigation is still ongoing, if any further information is found, a supplemental will be filed.

Event Description

It was reported that the or 7 light came off of the spring arm.There were no reported injuries or adverse consequences.

• Brand Name: PKG, VISUM LED 2 SURGICAL LIGHT, CAMERA READY
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 16523220
• MDR Text Key: 311258114
• Report Number: 0002031963-2023-00001
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327054347
• UDI-Public: 07613327054347
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2023

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: 0682001253
• Device Catalogue Number: 0682001253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/10/2023
• 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