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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 Problems Contamination (1120); Shipping Damage or Problem (1570)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
It was reported that there was a breach in 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.
 
Event Description
It was reported that there was a breach in sterile packaging.
 
Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: plastic trays were broken probable root cause: manufacturing/assembly/ service error incorrect or inadequate packaging severe shipping conditions user error the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
 
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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 Key14029999
MDR Text Key294540910
Report Number0002936485-2022-00168
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier37613327061391
UDI-Public37613327061391
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/30/2022
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
Device Operator Health Professional
Device Catalogue Number0250070500
Device Lot Number21325FG2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received04/06/2022
Supplement Dates Manufacturer Received03/10/2022
Supplement Dates FDA Received05/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2021
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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