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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION AC 3-CHIP AUTOCLAVABLE CAMERA, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION AC 3-CHIP AUTOCLAVABLE CAMERA, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 0700410105
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that a camera head was getting hot.
 
Event Description
It was reported that a camera head was getting hot.
 
Manufacturer Narrative
Alleged failure: ac precision cameras have been failing within 15 months of purchase.Image interference.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: camera head conforms to specifications.Provable root cause of the issue could be the scope or the light cord.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
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Brand Name
PKG, PRECISION AC 3-CHIP AUTOCLAVABLE CAMERA, C-MOUNT
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9578297
MDR Text Key179316916
Report Number0002936485-2020-00022
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327137378
UDI-Public07613327137378
Combination Product (y/n)N
PMA/PMN Number
K142603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0700410105
Device Catalogue Number0700410105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Date Manufacturer Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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