MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKEFLOW2 WITH DISPOSABLE TIP (6BX); APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 0250070520

Device Problem Hole In Material (1293)

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

Event Date 06/11/2015

Event Type  malfunction  

Event Description

It was reported that there was a hole in the tray.

Manufacturer Narrative

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

Manufacturer Narrative

The unit returned was received with the original label; therefore the lot number was confirmed.However, the blister package was not received, thus there was no way to observe any hole in the package or box as noted in the event description and received information.Thus, the damaged package condition could not be confirmed.There was no anomaly detected on the received unit nor any evidence that could support a hole in the box.No functionality testing is required due to investigation is related to package integrity.Probable root cause for the described condition can be associated, but not limited to: severe shipping conditions; incorrect or inadequate packaging; improper storage.There is no evidence to rule out none of the above thus root cause will remain as a multi-factorial of the three listed above.There were no delays, no additional medical intervention and no adverse effects reported in this event.Actual occurrence and severity are within predicted acceptable threshold.Risk is ranked as acceptably low.Procedures are in place to mitigate occurrence.The ifu contains instructions and warnings to the user regarding proper operation of the product.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a hole in the tray.

• Brand Name: STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• 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: 4900905
• MDR Text Key: 6023128
• Report Number: 0002936485-2015-00602
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070520
• Device Lot Number: 15119FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2015
• 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