MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; TUBESET FOR ARTHROSCOPY PUMP; ARTHROSCOPE

Catalog Number	0350202000
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
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 case was converted to open surgery due to potential piece of the spike remaining in the patient.
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.Alleged failure: iv spike broke.Probable root cause: - manufacturing/assembly error - tube set design.The device manufacture date is not known.
Event or Problem Description
It was reported that a case was converted to open surgery due to potential piece of the spike remaining in the patient.

• Brand Name: PKG; TUBESET FOR ARTHROSCOPY PUMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8529941
• Report Number: 0002936485-2019-00157
• Device Sequence Number: 19312747
• Product Code: HRX
• UDI-Device Identifier: 37613327061711
• UDI-Public: 37613327061711
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062380
• 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): 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0350202000
• Device Lot Number: 18A0014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other