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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number UNK_END
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2019
Event Type  Malfunction  
Manufacturer Narrative

Additional information will be provided once the investigation has been completed. The part number is unknown at this time, therefore the gtin and 510k are also unknown. 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 the surgery was cancelled while the patient was prepped and under anesthesia. There were no incisions made at the time of cancellation.

 
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Brand NameUNKNOWN_ENDOSCOPY_PRODUCT
Type of DeviceLAPAROSCOPE, 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
hannah stalnaker
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key10083173
MDR Text Key192151588
Report Number0002936485-2020-00206
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_END
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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