MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24FR 30° CUTTING LOOP ELECTRODE, .014 (6BX); ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number 0504880414

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

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

It was reported that the tip of the unit broke off, fell outside of the patient, and was retrieved.

Event Description

It was reported that the tip of the unit broke off, fell outside of the patient, and was retrieved.

Manufacturer Narrative

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

Manufacturer Narrative

The product was returned and the failure mode was confirmed.Visual inspection of the electrode revealed a broken off cutting loop tip.Three in total were received, but only two out of the three were unused and still sealed in their packages.The two electrodes were unsealed from their packages in order to perform a visual inspection.No damages were observed to both.Functional inspection: n/a the probable root causes for the cutting loop tip breaking off could be due to use error, user mishandling, or shipping issue.In sum, the product was returned and the failure mode was confirmed.

• Brand Name: 24FR 30° CUTTING LOOP ELECTRODE, .014 (6BX)
• Type of Device: ELECTRODE, ELECTROSURGICAL, 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: 3886912
• MDR Text Key: 4675797
• Report Number: 0002936485-2014-00418
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0504880414
• Device Lot Number: STRJL04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• 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