MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 3.0FR FLAT WIRE BASKET, 90CM; DISLODGER, STONE, FLEXIBLE

Catalog Number 0504803090

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.

Event Description

It was reported that a portion of the wire basket came off.It took 5-10 minutes to retrieve from the patient.No medical intervention and no adverse consequence.Procedure was completed successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Visual inspection: the metal piece that goes at the very end of the wires fell off.Functional inspection: the wire extended and retracted when the thumb slide was actuated back and forth.The probable root cause for the reported failure involving this device could be due to excessive force applied by user to device.Manufacture date is not known.(b)(4).

Event Description

It was reported that a portion of the wire basket came off.It took 5-10 minutes to retrieve from the patient.No medical intervention and no adverse consequence.Procedure was completed successfully.

• Brand Name: 3.0FR FLAT WIRE BASKET, 90CM
• Type of Device: DISLODGER, STONE, FLEXIBLE
• 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: 5472350
• MDR Text Key: 39697443
• Report Number: 0002936485-2016-00221
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0504803090
• Device Lot Number: STRAJ03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• 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