MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM, 45CM PEEK MONOPOLAR HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250181164

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

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

Event Date 01/06/2016

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.The following repair and service diagnostic codes were identified: cracked/peeling insulation at tip of shaft.Replaced handle.The following was observed: cracked / peeling insulation at tip of shaft.The handle was replaced.This does confirm the alleged failure mode of: insulation damage.Probable root cause: "poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Contact forces.Product used beyond defined useful life." furthermore, reportability decision was check for consistency.

Event Description

It was reported that insulation was cracked / peeling at tip of shaft.

• Brand Name: 5MM, 45CM 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: 5401772
• MDR Text Key: 37456885
• Report Number: 0002936485-2016-00100
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250181164
• Device Lot Number: ¿1446426H¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 02/01/2016
• 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