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

Model Number	100145CO2EXT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Hearing Loss (1882)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: STERILE WATER BOTTLE ADAPTER
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 6832231
• Report Number: 1651395-2017-00001
• Device Sequence Number: 1522027
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: 00677964059087
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K093665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100145CO2EXT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other