MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, GRASPER, 5FR SEMI FLEX; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0502555100

Device Problem Break (1069)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer 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 product broke.The broken pieces were retrieved and the procedure was completed successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: broke off in patient was retrieved no harm the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or rotational force with the jaw under load.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.(b)(4).

Event Description

It was reported that the product broke.The broken pieces were retrieved and the procedure was completed successfully.

• Brand Name: PKG, GRASPER, 5FR SEMI FLEX
• Type of Device: CYSTOSCOPE 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: roomi banerjee dua ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7152618
• MDR Text Key: 96117085
• Report Number: 0002936485-2017-01257
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502555100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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