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 Tissue Damage (2104); Injury (2348)

Event Date 07/19/2017

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.Gtin: (b)(4).

Event Description

It was reported that the surgeon cut the patients ureter.A surgical delay of 30 minutes occurred and an additional procedure was required to fix the injury.The procedure was completed the successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: rma #12086988.A doctor was utilizing the iris stent in a laparoscopic total hysterectomy and the surgeon cut across the ureter.The stent was still in tact but unable to see through tissue.The stent was still blinking after being cut which helped them identify the injury.Was not able to see the flashing red of the stent so was not able to see the blinking within the anamoty/through the tissue.Was able to see the patient¿s left side, but not the right side.Was not even sure if it was working.Was only able to see it after the ureter was cut.Urologist called in to fix the defect that was caused by the injury.Large surgical delay 3o min delay to bring urologist.An additional procedure in order to fix the injury salesforce.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be use error, handling error, or reaction forces.The device manufacture date is not known.(b)(4).

Event Description

It was reported that the surgeon cut the patients ureter.A surgical delay of 30 minutes occurred and an additional procedure was required to fix the injury.The procedure was completed the 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6793460
• MDR Text Key: 82656177
• Report Number: 0002936485-2017-00768
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151243
• 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
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0220180518
• Device Lot Number: 1927751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other