MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM, 33CM FENESTRATED GRASPER; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080755

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 12/09/2015

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.

Event Description

It was reported that the surgical assistant felt a pop and one of the jaws of the grasper flew off inside of the patient.Per stryker rep xrays were performed and the pieces were removed.Although there was patient involvement, there was no adverse consequence.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: use error, instrument wear, excessive device loads, reprocessing/handling error, contact forces.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.¿¿.

Event Description

It was reported that the surgical assistant felt a pop and one of the jaws of the grasper flew off inside of the patient.Per stryker rep xrays were performed and the pieces were removed.Although there was patient involvement, there was no adverse consequence.

• Brand Name: 5MM, 33CM FENESTRATED GRASPER
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5342413
• MDR Text Key: 35262666
• Report Number: 0002936485-2016-00011
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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