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
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.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.
Additional Manufacturer Narrative
Alleged failure: foreign material inside sterile package.Probable root cause: system design, assembly error, use error, component non-conformance.The device manufacture date is not known.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was foreign material inside of the sterile packaging.

• 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: 7617343
• Report Number: 0002936485-2018-00492
• Device Sequence Number: 16499506
• 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): 11/01/2018

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: 17H0288
• Was Device Available for Evaluation?: No
• 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: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1