MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 22 FR, 0 DEGREE (STRAIGHT) CUTTING LOOP ELECTRODE, .014; ELECTRODE, ELECTRO SURGICAL, ACTIVE, UROLOGICAL

Catalog Number 0504990500

Device Problems Break (1069); Component Falling (1105)

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

Event Date 06/03/2015

Event Type  malfunction  

Event Description

It was reported that the tips of the device broke inside of the patient.It was reported that the tip broke while using the resectoscope.The tips were recovered and sent in.

Manufacturer Narrative

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

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The cutting loop was visually inspected for damages, and the distal cutting tip has broken off of the insrument.Unable to function test the cutting loop due to the broken tip.The probable root causes could be handling during setup, or damaged during shipping.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 the tips of the device broke inside of the patient.It was reported that the tip broke while using the resectoscope.The tips were recovered and sent in.

• Brand Name: 22 FR, 0 DEGREE (STRAIGHT) CUTTING LOOP ELECTRODE, .014
• Type of Device: ELECTRODE, ELECTRO SURGICAL, ACTIVE, UROLOGICAL
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4877023
• MDR Text Key: 18029744
• Report Number: 0002936485-2015-00549
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0504990500
• Device Lot Number: 37576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• 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