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

Catalog Number 0620030407

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/27/2019

Event Type  malfunction  

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 Description

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

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 Description

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

• Brand Name: PKG.,HEATED INSUFLATOR TUBE SET
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8499575
• MDR Text Key: 141485290
• Report Number: 0002936485-2019-00137
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 37613327055628
• UDI-Public: 37613327055628
• Combination Product (y/n): N
• PMA/PMN Number: K003792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 0620030407
• Device Lot Number: 1873FE2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1