MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKEFLOW2 WITHOUT TIP (6BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070500

Device Problem Material Integrity Problem (2978)

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

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided once the investigation has been completed.

Event Description

It was reported a red ink stain was found on the tape that bundled the tube.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: stain (like red ink) on a tape that bundle tube the probable root cause/s could be incorrect or inadequate packaging, severe shipping conditions, improper cleaning.(b)(4).

Event Description

It was reported a red ink stain was found on the tape that bundled the tube.

• Brand Name: STRYKEFLOW2 WITHOUT TIP (6BX)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 5815566
• MDR Text Key: 51010408
• Report Number: 0002936485-2016-00698
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070500
• Device Lot Number: 16028FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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