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

Catalog Number 0250080234

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/25/2015

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 shaft insulation pulled away from tip.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.A gap between the tip and insulation was noticed.The pn and lot# etchings are not present.Also the insulation material appeared to be a non stryker part.The instrument is non monopolar, therefore an insulin scan was not performed.Ifu states "before use, ensure that there are no breaks, chips, cracks, scratches, tears, or missing/loose components on the shaft insulation, handle, or housing.Do not use the instrument if any of these defects are present as this could cause unintended electrosurgical burns and life threatening complications.If damage has occurred, discontinue use and return the instrument for repair or replacement." the probable root causes is third party repair.

Event Description

It was reported that shaft insulation pulled away from tip.

• Brand Name: 5MM RATCHETED HANDLE 33CM
• 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: 5312540
• MDR Text Key: 34603072
• Report Number: 0002936485-2015-01129
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250080234
• Device Lot Number: ¿11252015¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• 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