MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, WORKING ELEMENT, PASSIVE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0502880401

Device Problem Break (1069)

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

Event Date 01/10/2018

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 that the device broke.

Event Description

It was reported that the device broke.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: break off at the proximal end.Probable root cause: manufacturing/assembly error, severe shipping conditions, material/design error, damaged hardware/instrumentation, corrosion or rusting, use of incompatible instrumentation/hardware.Manufacture date is not known.Gtin: (b)(4).

• Brand Name: PKG, WORKING ELEMENT, PASSIVE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7246087
• MDR Text Key: 99311164
• Report Number: 0002936485-2018-00093
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0502880401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1