MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 4.0MM RESECTOR CUTTER, FORMULA (5BX); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0375542000

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 03/09/2015

Event Type  malfunction  

Event Description

It was reported that there was a red thread noticed in the packaging.

Manufacturer Narrative

The product was returned and the failure mode was confirmed.The resector was received out of the sterile packaging.The resector was visually inspected for damages, and none were present.However, a red particle was noticed on the resector.The red particle was confirmed to be part of the red hub near the proximal end, which could have been a left-over during the manufacturing process (induction welding of the housing tube into the red drive shaft).The drive shaft was hand spun to check the functionality, and the shaft was able to spin without issue.The probable root causes could be a piece of the red hub was left-over during the manufacturing process and not seen until it was jarred loose during shipping.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a red thread noticed in the packaging.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

• Brand Name: 4.0MM RESECTOR CUTTER, FORMULA (5BX)
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4649003
• MDR Text Key: 15588952
• Report Number: 0002936485-2015-00232
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0375542000
• Device Lot Number: 14357CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1