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

Model Number	CAT00241
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a piece broke off of the device during the procedure that led to a 45 minute delay.The piece was retrieved.
Additional Manufacturer Narrative
Alleged failure: a piece of the device broke off and had to be recovered from the patient.Surgical delay of 45min.Not longer.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) improper insertion, not enough force during insertion or 2) excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that a piece broke off of the device during the procedure that led to a 45 minute delay.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
• MDR Report Key: 9417148
• Report Number: 0002936485-2019-00534
• Device Sequence Number: 2927817
• Product Code: KDD
• UDI-Device Identifier: 07613252632863
• UDI-Public: 07613252632863
• Combination Product (Y/N): N
• 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): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CAT00241
• Device Catalogue Number: CAT00241
• Device Lot Number: 003865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1