MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0279401100

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that during a procedure, the serfas got caught between the femur and tibia.The white part of the tip became dislodged and remained in the joint.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Probable root cause for the reported failure involving this device could have been caused by: non-conforming component, poor assembly process, misuse.Use error.(b)(4).

Event Description

It was reported that during a procedure, the serfas got caught between the femur and tibia.The white part of the tip became dislodged and remained in the joint.

• Brand Name: 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 5584964
• MDR Text Key: 42910823
• Report Number: 0002936485-2016-00367
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

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: 0279401100
• Device Lot Number: 15153AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2015
• 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
• Patient Outcome(s): Other