STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-04-15 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy San Jose.

Event Text Entries

[1976587] It was reported that the customer is concerned about the safety of the product as the bolts on the mount need to be re-tightened on a monthly basis. This is done in order to hold the arm on the metal plate. When monitors are mounted on the product, they often drift into the field. The monitors have to be secured with velcro. It was further reported that the product dropped and landed on the end of the bed.
Patient Sequence No: 1, Text Type: D, B5


[9109433] Add'l info will be provided once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2936485-2011-00236
MDR Report Key2087301
Report Source00,07
Date Received2011-04-15
Date of Report2011-03-22
Date of Event2011-03-22
Date Mfgr Received2011-03-22
Date Added to Maude2011-07-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSUNNY OFFORJEBE
Manufacturer Street5900 OPTICAL CT.
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY SAN JOSE
Manufacturer Street5900 OPTICAL CT.
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal Code95138
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTRYKERVISION FLAT-PANEL MOUNTING ARM
Generic NameMOUNTING ARM
Product CodeODA
Date Received2011-04-15
Catalog Number0240095200
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY SAN JOSE
Manufacturer AddressSAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2011-04-15

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