MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 22 FR, COLLINGS KNIFE ELECTRODE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504990800

Device Problems Corroded (1131); Device Packaging Compromised (2916); Knife (3156)

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

Event Date 04/23/2018

Event Type  Malfunction  

Manufacturer Narrative

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. (b)(4).

Event Description

It was reported that the sterile packaging may have been contaminated; causing the knife to be rusted.

Manufacturer Narrative

Alleged failure: the end of the knife is rusted the failure(s) identified in the investigation is consistent with the complaint record. The probable root cause could be manufacturing process sterility. The product was returned for investigation and the failure mode will be monitored for future reoccurrence. The device manufacturer date is not known.

Event Description

It was reported that the sterile packaging may have been contaminated; causing the knife to be rusted.

• Brand Name: PKG, 22 FR, COLLINGS KNIFE ELECTRODE
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7527912
• MDR Text Key: 108866503
• Report Number: 0002936485-2018-00437
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: CN
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/18/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device Catalogue Number: 0504990800
• Device LOT Number: STRKN01
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2018
• 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