MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW INFLOW CASSETTE TUBI; ARTHROSCOPE

Catalog Number 0450000100

Device Problems Loose or Intermittent Connection (1371); Torn Material (3024)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that the sharpness of the spike tore the rubber safety of the fluid bag and loose debris flowed into the fluid.

Manufacturer Narrative

The product was not returned for investigation.Therefore, the reported failure mode could not be confirmed.The possible root cause for the failure can be due to the saline bag, which makes this unit a concomitant product.However, this cannot be confirmed since the unit was not returned.In the event that the unit is returned, a full evaluation will be conducted and a follow up report will be issued.

Manufacturer Narrative

The product was returned and the failure mode was confirmed.Visual inspection : only the cut plastic spike was received together with the b braun saline bag.A piece of spike adaptor was found taped on the saline bag.Probable root causes could be (1) the b braun saline bag spike adaptor has a known issue to break when being spiked (2) the saline bag was spiked on an angle and not on the middle part of the spike adaptorr (3) defective saline bag (4) user error in sum, the product was returned and the failure mode was confirmed.

Event Description

It was reported that the sharpness of the spike tore the rubber safety of the fluid bag and loose debris flowed into the fluid.

• Brand Name: CROSSFLOW INFLOW CASSETTE TUBI
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: elsa abarca ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3903627
• MDR Text Key: 4540570
• Report Number: 0002936485-2014-00440
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0450000100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1