MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 3.5MM 90-S SERFAS ENERGY SUCTION PROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0279351100

Device Problems Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.Lot number is unknown; therefore, manufacture date can not be confirmed gtin: (b)(4).

Event Description

It was reported that the metal tip fell out of the wand into the knee and the piece was not recovered.There was a 45 minute delay.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: metal tip itself fell out of the wand into the knee and the joint piece was not recovered.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive force used when inserting of removing probe, probe inserted into obstructed passageway or any forceful impact to the tip of the probe with rigid objects.Probe used as a tool for mechanical displacement of tissue or bone, or to pry or scrub.The reported failure mode will be monitored for future reoccurrence.Mfg date: 05/06/2016.(b)(4).

Event Description

It was reported that the metal tip fell out of the wand into the knee and the piece was not recovered.There was a 45 minute delay.

• Brand Name: 3.5MM 90-S 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: 5855417
• MDR Text Key: 51444095
• Report Number: 0002936485-2016-00722
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071859
• 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: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0279351100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• 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