MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE IRIS URETERAL KIT; LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL

Catalog Number 0220180518

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Urinary Retention (2119)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture 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 patient was unable to pass urine normally due to the swelling of the ureters, requiring an additional medical procedure.The procedure was completed successfully.

Manufacturer Narrative

Alleged failure: swelling.Probable root causes: printed markings missing, inconsistently spaced, or otherwise incorrect.Incorrect device dimensions, user confusion.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.Lot number is unknown; therefore, manufacture date can not be confirmed.Gtin: (b)(4).

Event Description

It was reported that the patient was unable to pass urine normally due to the swelling of the ureters, requiring an additional medical procedure.The procedure was completed successfully.

• Brand Name: IRIS URETERAL KIT
• Type of Device: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• 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: sandhya jaishankar ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6472340
• MDR Text Key: 72116267
• Report Number: 0002936485-2017-00354
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K151243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0220180518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• 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
• Patient Outcome(s): Other