MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG.,HEATED INSUFLATOR TUBE SET; HOLOGRAPH, FETAL, ACOUSTICAL

Catalog Number	0620030407
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
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 there was foreign material inside of the sterile packaging.
Event or Problem Description
It was reported that there was foreign material inside of the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: particulate in sealed packaging.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be extreme shipping conditions or flash during the manufacturing process came loose during shipping.The product was returned for investigation and the failure mode was not confirmed and will be monitored for future reoccurrence.

• Brand Name: PKG.,HEATED INSUFLATOR TUBE SET
• Common Device Name: HOLOGRAPH, FETAL, ACOUSTICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7617466
• Report Number: 0002936485-2018-00495
• Device Sequence Number: 2193946
• Product Code: HIF
• UDI-Device Identifier: 37613327055628
• UDI-Public: 37613327055628
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K003792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 0620030407
• Device Lot Number: 15309FE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1