MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., TOMCAT SHAVER BLADE, F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375545000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that a foreign material was found in the sterile packaging.
Event or Problem Description
It was reported that a foreign material was found in the sterile packaging.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: foreign material inside sterile packaging.Probable root cause: - improper environmental conditions - shipping & handling - inadequate positioning of the device into the primary package.

• Brand Name: PKG., TOMCAT SHAVER BLADE, F - SERIES - 4.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8793346
• Report Number: 0002936485-2019-00298
• Device Sequence Number: 10846567
• Product Code: GFA
• UDI-Device Identifier: 37613327061797
• UDI-Public: 37613327061797
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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
• Operator of Device: Other
• Device Catalogue Number: 0375545000
• Device Lot Number: 18120CE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1