MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5); LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL

Catalog Number 0220180517

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2017

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 stent not properly illuminating.Although there was patient involvement, there was no adverse consequence.

Manufacturer Narrative

Alleged failure: bent inside sterile packaging.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a shipping error as the sterile packaging is bent.However, upon further investigation and testing, the bent packaging did not cause the product to fail.The product failing could be a result of user error or the customer's l10 unit not having the ability to emit enough light.Furthermore, it is not ruled out that the bent packaging could still cause the product to degrade over time as the initial fault was not noticed.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.(b)(4).

Event Description

It was reported that the stent not properly illuminating.Although there was patient involvement, there was no adverse consequence.

• Brand Name: PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)
• 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: 6644855
• MDR Text Key: 77729656
• Report Number: 0002936485-2017-00559
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061548
• 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: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0220180517
• Device Lot Number: 1694987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• 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