Lot number: subjected lots: 180913, 180922, 180925,180926, 181010, 181013, 181024, and 181025, which were manufactured in september 2018 - october 2018.Expiration date - unknown due to unknown lot number.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number the actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product release decision control sheets of the product code/lot#' (manufactured in september 2018 - october 2018) combinations were conducted with no findings.Review of the biological safety tests results for the past three years did not find any deviation or nonconformity in the records.In the product design stage, this product was verified to meet the biological safety criteria (cytotoxicity test, skin sensitization test, intradermal reaction test, acute toxic reaction, pyrogenic substance test, and haemolysis test) in accordance with iso10933.(b)(4) factory performs the following safety tests regularly: sterilization test (iso11135): per sterilization batch; endotoxin test(jp standard ): per production lot; extraction test (approval standard for disposable device sets for artificial heart-lung machine): once every six months; and eto residual (eo and ech) test (iso10993-7): once every four months.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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The user facility reported that they have noticed an issue with the patient experiencing what seems to be pain, muscle spasms/twitching or discomfort during sphincterotomy.Ercp potential visiglide guidewire concern.They have had their diathermy tested by ebme (reported fine) and they have apparently noticed that if they retract the guidewire almost; however, not quite fully into the sphincterotome when any pain/spasm type symptoms occur with the patient that these issues no longer occur.They feel through the process of elimination the guidewire is the potential issue/common factor.The procedure was completed on (b)(6) 2019.The endoscopist described it to be "distressing electric shocks" which were felt by the nurse as well.The accessory used: olympus guide wire -visi guide.The patient felt twitching/pulsation, muscle cramps, tingling, discomfort, etc., which appeared to be painful.The procedure outcome was not reported.
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