MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, SEMI-RIGID URETEROSCOPE, 43CM; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0502880430

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

This scope was not received for investigation at stryker endoscopy because it was investigated by the legal manufacturer, (b)(4).Alleged problem(s): damage to working channel alleged problem confirmed: yes according to (b)(4): visual inspection: scope was evaluated by eye, with eye loupe and microscope to determine that the scope has a cracked needle weld.Functional inspection: scope was evaluated by eye, with eye loupe and camera system to determine that the image is dark and hazy due to the cracked needle weld.Probable root cause: thermal destruction of epoxy, improper/third party repair , improper epoxy/curing process, laser welding failure, use error, contact with instrument.The product was returned to (b)(4) for investigation and the failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the guide wire broke inside of the patient.The broken pieces were removed and the procedure was completed successfully.

Manufacturer Narrative

This scope was not received for investigation at stryker endoscopy because it was investigated by the legal manufacturer, henke.The product was returned to henke for investigation and the failure mode will be monitored for future reoccurrence.Alleged problem: damage to working channel.Alleged problem confirmed: yes.Probable root cause: thermal destruction of epoxy.Improper/third party repair.Improper epoxy/curing process.Laser welding failure.Use error.Contact with instrument.Gtin: (b)(4).

Event Description

It was reported that the guide wire broke inside of the patient.The broken pieces were removed and the procedure was completed successfully.

• Brand Name: PKG, SEMI-RIGID URETEROSCOPE, 43CM
• Type of Device: URETEROSCOPE 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: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6529661
• MDR Text Key: 74162222
• Report Number: 0002936485-2017-00399
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121112
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502880430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1