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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA CONTROL UNIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA CONTROL UNIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 1288010000
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/05/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Alleged failure: producing smoke.The failure identified in the investigation is consistent with the complaint record.Root cause: ic u27 shorted out.This is an electrical component failure and it is difficult to predict the life time of electrical components.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event or Problem Description
It was reported that there was a thermal event.
 
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Brand Name
PKG 1288HD CAMERA CONTROL UNIT
Common Device Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key8203583
Report Number0002936485-2018-00733
Device Sequence Number1901134
Product Code GCJ
UDI-Device Identifier07613327063387
UDI-Public07613327063387
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K132785
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/28/2018
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
Operator of Device Other
Device Catalogue Number1288010000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2018
Initial Report FDA Received Date12/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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