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

Catalog Number 0250080234

Device Problems Crack (1135); Peeled/Delaminated (1454)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known.Alleged failure: cracked/peeling insulation at tip of shaft confirmed failure: cracked/peeling insulation at tip of shaft.Probable root cause: handling procedures.Use error.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the handle had cracked/peeling insulation at the tip of the shaft.There was no patient involvement and therefore no adverse consequence.

• 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: 5937895
• MDR Text Key: 54683075
• Report Number: 0002936485-2016-00869
• 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
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250080234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Date Manufacturer Received: 08/16/2016
• 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