MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG OPMI PICO ON S100 FLOOR STAND; MICROSCOPE, SURGICAL, GENERAL AND PLA

Model Number S100 FLOORSTAND

Device Problem Installation-Related Problem (2965)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

It was reported that the customer heard a noise and went into the procedure room.They found the lamp housing (xenon power supply illumination unit) had fallen and was hanging by the cables from their opmi pico microscope s100 floor stand.The customer confirmed that no one was injured.

Manufacturer Narrative

The field service engineer (fse) found that all four bolts securing the xenon power supply illumination unit mounting plate to the s100 stand were broken.The microscope was repaired.Site contact is same as initial reporter.

• Brand Name: OPMI PICO ON S100 FLOOR STAND
• Type of Device: MICROSCOPE, SURGICAL, GENERAL AND PLA
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; oberkochen ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC, INC. JUDY BRIMACOMBE; 5160 hacienda dr; dublin CA 94568
• Manufacturer Contact: judy brimacombe ; carl zeiss strasse 22; oberkochen 73447 ; GM 73447 ; 9255574616
• MDR Report Key: 3894155
• MDR Text Key: 4654518
• Report Number: 9615010-2014-00006
• Device Sequence Number: 1
• Product Code: FSO
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S100 FLOORSTAND
• Device Catalogue Number: 000000-1403-542
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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