MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG.,HEATED INSUFLATOR TUBE SET; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620030407
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.Mfg date: manufacture date is not known at this time.However, if it becomes available it will be provided in future reports.
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 product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8499575
• Report Number: 0002936485-2019-00137
• Device Sequence Number: 1870892
• Product Code: HIF
• UDI-Device Identifier: 37613327055628
• UDI-Public: 37613327055628
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K003792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 1873FE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1