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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AHTO IRRIGATION PUMP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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STRYKER ENDOSCOPY-SAN JOSE PKG., AHTO IRRIGATION PUMP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Catalog Number 0250070601
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was a thermal event.There was no associated procedure and no reports of adverse consequences.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: battery got warm.Probable root cause: material/design error, manufacturing/assembly error, user error.
 
Event Description
It was reported that there was a thermal event.There was no associated procedure and no reports of adverse consequences.
 
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Brand Name
PKG., AHTO IRRIGATION PUMP
Type of Device
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7724115
MDR Text Key115277774
Report Number0002936485-2018-00551
Device Sequence Number1
Product Code GCX
UDI-Device Identifier07613327052138
UDI-Public07613327052138
Combination Product (y/n)N
PMA/PMN Number
K042454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0250070601
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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