MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24FR 90° CUTTING LOOP ELECTRODE, .012 (6BX); CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504880312

Device Problem Break (1069)

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

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported electroloop at the distal tip broke off in patient.Tip was retrieved.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: electroloop at the distal tip broke off in patient it was retrieved.The probable root causes could be power set too high, generator power malfunction, or overuse.The reported failure mode will be monitored for future reoccurrence.(b)(4).Mfg date: manufacture date is not known.

Event Description

It was reported electroloop at the distal tip broke off in patient.Tip was retrieved.

• Brand Name: 24FR 90° CUTTING LOOP ELECTRODE, .012 (6BX)
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 6045827
• MDR Text Key: 58028827
• Report Number: 0002936485-2016-00992
• Device Sequence Number: 1
• Product Code: FAJ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0504880312
• Device Lot Number: STRGN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• 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