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

Catalog Number 0375544000

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

It was reported that there was foreign material found inside the sterile packaging.

Manufacturer Narrative

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

Manufacturer Narrative

Upon visual inspection of the returned unit, the reported foreign material (hair) was confirmed.A human hair strand was observed trapped within the product blister and tyvek seal.Based on investigation findings, the most likely root cause for subject foreign material is workmanship-related (procedures not followed), since the hair was not captured during the particles inspection check or packaging stage.According to event details information in the product inquiry record, there was no patient involvement or associated procedure; the non-conformance was noticed prior to procedure.In sum, the unit was returned and the reported failure mode was confirmed.

Event Description

It was reported that there was foreign material found inside the sterile packaging.

• Brand Name: 4.0MM AGGRESSIVE PLUS 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: 4052789
• MDR Text Key: 16175064
• Report Number: 0002936485-2014-00642
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375544000
• Device Lot Number: 14104CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• 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