MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PORTAL ENTRY KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number	CAT00241
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire broke.The piece was retrieved.
Additional 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.
Additional Manufacturer Narrative
The device manufacturer date is not known.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: guidewire broke probable root cause: design; tip not sharp enough.Process: tip not manufactured to specification.Application: improper insertion, not enough force during insertion.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
Event or Problem Description
It was reported that the guidewire broke.The piece was retrieved.

• Brand Name: PORTAL ENTRY KIT
• Common Device Name: KIT, SURGICAL INSTRUMENT, 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 Key: 13229406
• Report Number: 0002936485-2022-00027
• Device Sequence Number: 19911743
• Product Code: KDD
• UDI-Device Identifier: 07613252632863
• UDI-Public: 07613252632863
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: CAT00241
• Device Catalogue Number: CAT00241
• Device Lot Number: 006646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown