MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HIGH FLOW HEATED INSUFFLATOR TUBING (5BX); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620030407

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 05/08/2015

Event Type  malfunction  

Event Description

It was reported that there was a piece of metal in the packaging.

Manufacturer Narrative

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

Manufacturer Narrative

The foreign material failure mode was confirmed on the unit returned.A small strand of wire was found inside the package.As per risk document most probable root causes are: 1.Manufacturing error; 2.Damage during shipment (inadequate packaging); 3.Damage during shipment (abuse during transit).The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a piece of metal in the packaging.

• Brand Name: HIGH FLOW HEATED INSUFFLATOR TUBING (5BX)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4816627
• MDR Text Key: 19500684
• Report Number: 0002936485-2015-00451
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0620030407
• Device Lot Number: 15044FE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1