MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. SHEATH, 45CM STRYKEPROBE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070450
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the end of sheath broke off inside the patient.Broken piece was recovered from the patient and the procedure was completed.
Additional Manufacturer Narrative
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.The reported failure mode will be monitored for future reoccurrence alleged failure: broke off inside the patient.Probable root cause: 1.Material/design error 2.Manufacturing/assembly/ service error 3.Excessive user force 4.Severe shipping conditions 5.Disposable tip rubbing against product 6.User error manufacture date is not known.
Event or Problem Description
It was reported that the end of sheath broke off inside the patient.Broken piece was recovered from the patient and the procedure was completed.

• Brand Name: PKG. SHEATH, 45CM STRYKEPROBE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9078130
• Report Number: 0002936485-2019-00401
• Device Sequence Number: 2486064
• Product Code: GCJ
• UDI-Device Identifier: 07613327051926
• UDI-Public: 07613327051926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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 Catalogue Number: 0250070450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1