MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW CONSOLE; ARTHROSCOPE

Catalog Number 0450000000

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported dr.Performed the surgery on (b)(6) 2016.All went well; case went from 11:26am to 12:13pm; he used 2 spiked bags.Patient came back for follow up on (b)(6) and the shoulder was blown up.

Manufacturer Narrative

(b)(4).The product was returned and the failure mode was not confirmed.The use history of the pump (s/n (b)(4) was pulled, and the daylog files indicated that the pump was not used on (b)(6) 2016, which is the date that the surgery resulting in joint overpressure was performed.Visual inspection : no physical damages seen on the unit.Seal was intact.Functional inspection: the pump booted up with the following software version: 01.04.05.The critical error log was reviewed and there were no errors related to the complaint.There was no entry in the daylogs folder that a surgery was performed on (b)(6) 2016 as mentioned in the complaint an inflow/outflow cassette tube set was inserted into the pump and connected with a crossfire console using a firewire cable.The crossfire had a footswitch, shaver, and rf probe connected.The crossflow tube sets were connected to a water source and joint test fixture that included a pressure sensor transducer.The pump was then run on standard settings.A set pressure of 50mm hg, 80mm hg and 120mm hg with suction percentages of 30%, 20% and 10% respectively per pressure setting.For each pressure setting, pressure was applied to the joint test fixture membrane and a shaver and rf probe were activated.The testing confirmed that the pump was able to recover and then maintain the set pressures within +/- 15mm hg during membrane depressions and handpiece activations.For each corresponding suction setting, the resulting suction output was normal.No issues observed during testing.Final qc procedure was performed and passed.The customer complaint was not duplicated, no problem found.The probable root cause/s could be (1) user settings (2) kinked outflow tubing.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported dr.Performed the surgery on (b)(6) 2016 all went well case went from 11:26am to 12:13pm he used 2 spiked bags.Patient came back for follow up on (b)(6) and the shoulder was blown up.

• Brand Name: CROSSFLOW CONSOLE
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5495206
• MDR Text Key: 40168680
• Report Number: 0002936485-2016-00254
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other