MAUDE Adverse Event Report: MEDIVATORS ENDO SMARTCAP STERILE WATER BOTTLE ADAPTER

Model Number 100145CO2EXT

Device Problems Cap (424); Crack (1135)

Patient Problem Hearing Loss (1882)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

Facility reported they have been having issues with their endo smartcaps cracking and popping off their co2 insufflators. In one instance, the smartcap popped off the water bottle and resulted in an audible noise which the doctor in the procedure room complained was very loud. It was reported that this doctor had a hearing test done, thus potential injury is being reported. This is the only facility medivators has received complaints from of this issue. Medivators product specialists and sales representative visited the facility numerous times to investigate this issue and determine the cause of the endo smartcaps cracking. It was observed and noted that the facility recently started using pdi sani-cloth af3 germicidal disposable wipes to wipe down all equipment between procedures to the point that everything is dripping wet. The technicians would pull out approximately an arm's length of wipes and squeeze the liquid onto the carts then wipe it all over everything and allow it to air dry between procedures. Medivators continues to investigate through internal testing of the products and continues to work closely with the facility to resolve this issue. This facility did not disclose the hearing test documentation of the affected physician. This is an isolated, unusual event and there have been no reports of patient harm. Medivators will continue to monitor this complaint and it will be maintained within medivators complaint system.

Event Description

A facility reported that the endo smart cap popped off of the reusable water bottle and made a loud noise. It was reported that the doctor at the facility had a hearing test done as a result of the loud noise, thus potential injury is being reported.

• Brand Name: ENDO SMARTCAP
• Type of Device: STERILE WATER BOTTLE ADAPTER
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6832231
• MDR Text Key: 84073599
• Report Number: 1651395-2017-00001
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K093665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/30/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 100145CO2EXT
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 08/30/2017 Patient Sequence Number: 1