MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SPY-PHI DRUG DRAPE KIT; COVER, BARRIER, PROTECTIVE

Catalog Number HH9006

Device Problems Delivered as Unsterile Product (1421); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the sterile drape was not sealed completely.No adverse consequences were reported.

Manufacturer Narrative

Alleged failure: "drape isn't sealed completely" probable root cause/s: reported issue is likely due to a failure of the bottom pouch seal.This seal is applied in-house by drape oem premier guard and oem investigation is ongoing to determine root cause.The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the sterile drape was not sealed completely.No adverse consequences were reported.

• Brand Name: SPY-PHI DRUG DRAPE KIT
• Type of Device: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• MDR Report Key: 9188766
• MDR Text Key: 167982100
• Report Number: 3012345110-2019-00009
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• PMA/PMN Number: K041501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Catalogue Number: HH9006
• Device Lot Number: 1906241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1