MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BIOPSY PUNCH 5FR SEMI FLE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0502555200

Device Problems Device Contamination with Chemical or Other Material (2944); Cannula (3036)

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

Event Date 04/28/2016

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 while using a biopsy punch, bioburden, rust and shiny material came out of the cannula.

Manufacturer Narrative

"alleged failure: rust and metal debris probable root cause: "material/design error. Manufacturing/assembly error. Inadequate package seal strength (packaging design). Improper cleaning/sterilization for reusable devices". The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. The device manufacturer date is not known. Gtin: (b)(4).

Event Description

It was reported that while using a biopsy punch, bioburden, rust and shiny material came out of the cannula.

• Brand Name: BIOPSY PUNCH 5FR SEMI FLE
• 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: 5674792
• MDR Text Key: 45793188
• Report Number: 0002936485-2016-00491
• 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

• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/23/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 0502555200
• Device LOT Number: N/A
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse