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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., SUCTION / IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., SUCTION / IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0250070500
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
Event Type  malfunction  
Event Description
It was reported that there was foreign material inside the sterile packaging.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
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Brand Name
PKG., ASSY., SUCTION / IRRIGATOR 2
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key18145562
MDR Text Key328226346
Report Number0002936485-2023-01152
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier37613327061391
UDI-Public37613327061391
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0250070500
Device Lot Number22332F G2
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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