MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C3001, SCOPE WARMER BOTTLE; GCJ

Model Number	C3001
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Sterilization- "recently, the endoscope heaters at this hospital become distorted significantly after 10 sterilizations.To remove this problem, they went from 18 minutes sterilization 134 degrees to 125 degrees and thus at less pressure.But the phenomenon persists.Customer gave me a copy with the internal walls of the heater completely distorted and not allowing its use.Similarly they found that water was stagnant in the double wall of the endoscope heater." additional information received from customer relations: lot number is 1236790.Type of intervention: "to remove this problem, they went from 18 minutes sterilization 134 degrees to 125 degrees and thus at less pressure.But the phenomenon persists." patient status: 'unknown".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering noted that the bottle had dents, scratches and rust near the welding.Water could be heard inside the canister walls.The likely root cause of the water inside the canister walls is due to improper storage, cleaning or usage conditions.While the applied medical scope warmer bottle is designed to be re-usable, the life span of the device is dependent on the conditions the device experiences.The observed dents and scratches on the bottle could have allowed water into the walls during sterilization.The instructions for use (ifu) state, "handle with care.Product should be stored in a clean, cool, dry area away from chemical fumes." all applied medical scope warmers are 100% inspected prior to packaging.It is unknown what conditions the product experienced during and after shipping from applied medical.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: C3001, SCOPE WARMER BOTTLE
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5891676
• Report Number: 2027111-2016-00595
• Device Sequence Number: 421751
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)300115(30)01(10)1236790
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K931895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: C3001
• Device Catalogue Number: 100260501
• Device Lot Number: 1236790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2016
• Supplement Report FDA Received Date: 10/17/2016
• Patient Sequence Number: 1