MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., PUMP CANNULA, 5.8MM W/ 1 ROTATIONG STOPCOCK; ARTHROSCOPE.

Catalog Number	0747031530
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the o-ring came off and into the patient's knee.The o-ring was retrieved and procedure was completed successfully.
Event or Problem Description
It was reported that the o-ring came off and into the patient's knee.The o-ring was retrieved and procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: during a knee arthroscopy, its was reported when using the single stopcock cannula 0747-031-530 the o ring has come out of the cannula and gone into the patient's knee.The o ring was retrieved with no impact to the patients knee.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be rough handling and/or improper sterilization methods.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., PUMP CANNULA, 5.8MM W/ 1 ROTATIONG STOPCOCK
• Common Device Name: ARTHROSCOPE.
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8586402
• Report Number: 0002936485-2019-00189
• Device Sequence Number: 14023669
• Product Code: NBH
• UDI-Device Identifier: 07613327054576
• UDI-Public: 07613327054576
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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: 0747031530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1