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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ASSY, RP 360 DEG SUTURE PASSER NEEDLE, BOX OF 5 NEEDLE, SUTURING, DISPOSABLE
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STRYKER ENDOSCOPY-SAN JOSE ASSY, RP 360 DEG SUTURE PASSER NEEDLE, BOX OF 5 NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Catalog Number 3910-900-091
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  Injury  
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. Filing on behalf of oem coorstek.
 
Event Description
It was reported that the broken tip of the device potentially remains in the patient.
 
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Brand NameASSY, RP 360 DEG SUTURE PASSER NEEDLE, BOX OF 5
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
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
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key11016131
MDR Text Key221734676
Report Number0002936485-2020-00521
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K831648
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 04/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3910-900-091
Device Lot Number1900725
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 Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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