MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .012 WIRE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504880312

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip broke off.The broken piece was retrieved and the procedure was completed successfully.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: tip broke off.Probable root cause: 1.User excessive force or torque.4.User error in not properly inspecting unit prior to use.6.Constant irrigation flow is not maintained leading to limited field of view.8.Incompatible instrumentation used with electrode.The device manufacturer date is not known.Gtin: (b)(4).

Event Description

It was reported that the tip broke off.The broken piece was retrieved and the procedure was completed successfully.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: tip broke off.Probable root cause: user excessive force or torque, user error in not properly inspecting unit prior to use, constant irrigation flow is not maintained leading to limited field of view, incompatible instrumentation used with electrode.The device manufacturer date is not known.(b)(4).

Event Description

It was reported that the tip broke off.The broken piece was retrieved and the procedure was completed successfully.

• Brand Name: PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .012 WIRE
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6552458
• MDR Text Key: 74830443
• Report Number: 0002936485-2017-00437
• 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,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• 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: LN STENLA02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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