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

Model Number CAT00241

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the guidewire broke.The piece was retrieved.

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.

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 Description

It was reported that the guidewire broke.The piece was retrieved.

• Brand Name: PORTAL ENTRY KIT
• Type of Device: 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
• MDR Text Key: 285937635
• Report Number: 0002936485-2022-00027
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 07613252632863
• UDI-Public: 07613252632863
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 03/09/2022
• 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 Sequence Number: 1