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

Catalog Number 0747031550

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event 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.

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 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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9497619
• MDR Text Key: 177425864
• Report Number: 0002936485-2019-00590
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327054590
• UDI-Public: 07613327054590
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 0747031550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1