MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS IN LIGHT ZOOM CAMERA; LED IN-LIGHT CAMERA

Catalog Number 0682000163

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that the led in-light camera cover allegedly came off and struck a patient during a case.Account or staff didn't know that the cover had struck the patient in the case until after the patient was removed from the operating room.The patient had to have stitches where the cover struck them.The (b)(6) of the account stated that they felt that the cover coming off was due to use error and not an equipment malfunction.There have not been any adverse consequences for similar events in the past.

Event Description

It was reported that the led in-light camera cover came off and struck a patient during a case.Allegedly, the patient had to have stitches where the cover struck them.The (b)(6) of the account stated that they felt that the cover coming off was user error and not a equipment malfunction.There have not been any adverse consequences for similar events in the past.

• Brand Name: IN LIGHT ZOOM CAMERA
• Type of Device: LED IN-LIGHT CAMERA
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer Contact: adam gorzeman ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 5255101
• MDR Text Key: 32317380
• Report Number: 0002031963-2015-00013
• Device Sequence Number: 1
• Product Code: KQM
• 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
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0682000163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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