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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3-CHIP CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3-CHIP CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1488610122
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that the camera head was overheating during a procedure.
 
Manufacturer Narrative
Alleged failure: camera got hot during case.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: the cable has an internal short to ground causing the camera head to slightly over-heat intermittently.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that the camera head was overheating during a procedure.
 
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Brand Name
PKG, 1488 HD 3-CHIP CAMERA HEAD WITH INTEGRATED COUPLER
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9777570
MDR Text Key186209687
Report Number0002936485-2020-00110
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327061000
UDI-Public07613327061000
Combination Product (y/n)N
PMA/PMN Number
K132785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1488610122
Device Catalogue Number1488610122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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