MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., PUMP CANNULA,5.8MM W/2 ROTATING STOPCOCKS; ACCESSORIES,ARTHROSCOPIC

Catalog Number	0747031550
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
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 went into the patient's knee.The o-ring was retrieved and procedure was completed successfully.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: beatrice rochette (customer) reported to the ansm that : "during surgery, a round joint is found in the knee joint.Unknown provenance.After observation the "arthroscope outter sheath" leaks.Change of material same problem, which prevents us from getting the joint back.After another change of material, we were able to remove the joint thanks to the shaver.I filtered 1 suction, to make sure i got everything back.Current state of the patient : extension of the operation, risk of leaving a foreign body actions taken in the care facility for patient care : suction of the seal thanks to a shaver actions undertaken in the establishment : return to the supplier of the folders for inspection".The probable root cause/s could be rough handling and/or improper sterilization methods.
Event or Problem Description
It was reported that the o-ring came off and went into the patient's knee.The o-ring was retrieved and procedure was completed successfully.

• Brand Name: PKG., PUMP CANNULA,5.8MM W/2 ROTATING STOPCOCKS
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9497619
• Report Number: 0002936485-2019-00590
• Device Sequence Number: 1742908
• Product Code: NBH
• UDI-Device Identifier: 07613327054590
• UDI-Public: 07613327054590
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 0747031550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1