MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 10MM PEEK MONOPOLAR HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080618

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

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

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: cracked/peeling insulation at tip of shaft.Confirmed failure: cracked/peeling insulation at tip of shaft.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life.The device manufacture date is not known.(b)(4).

Event Description

It was reported cracked and peeling insulation at tip of shaft.

• Brand Name: PKG, 10MM PEEK MONOPOLAR HANDLE
• 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: 6079158
• MDR Text Key: 59340663
• Report Number: 0002936485-2016-01032
• 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
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250080618
• Device Lot Number: ¿1146661D¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Date Manufacturer Received: 10/11/2016
• 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