MAUDE Adverse Event Report: PENUMBRA, INC. APOLLO CANISTER; GWG

Device Problems Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a microneurosurgery using the apollo system.During preparation for the procedure, it was noticed that the apollo canister cup holder (holder) bracket was broken on one side.The hospital staff secured the holder with tape and it worked fine for the procedure.During the procedure, upon initiating aspiration and irrigation, it was noticed that the peristaltic pump clamp on the apollo generator (generator) was not working properly, and failed to properly secure the apollo irrigation tubing (tubing).The tubing remained secure from advancing by the pump and worked fine.There was minimal time delay as the pump and tubing continued to work throughout the procedure despite the tubing connector advancing too close to the pump.The procedure was completed using the same apollo system.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the canister holder tab was broken.Conclusions: evaluation revealed that the canister holder was broken.This type of damage typically occurs due to improper handling.If the canister was overtightened while attaching the canister holder to the apollo system, damage such as this may occur.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: APOLLO CANISTER
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5867145
• MDR Text Key: 51827115
• Report Number: 3005168196-2016-01153
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• 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