It was reported that during the surgery, this product didn't work on low mode unless the surgeon keeps gripping the switch and it also stopped working on high mode in a short time.In photos included with the event, one of the batteries expelled acid.No adverse events were reported as a result of this malfunction.
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D4: udi# (b)(4).Reported issue: it was reported that during the surgery, this product didn't work as usual.This product didn't work on low mode unless the surgeon keep gripping the switch.And this product stopped working on high mode in a short time.The device history record (dhr) for 00515047501 lot number 64245213, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) hospital that during the surgery, this product didn't work as usual.This product didn't work on low mode unless the surgeon keep gripping the switch.And this product stopped working on high mode in a short time.On 12 august 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device was not working as intended, and further review noted corrosion in the battery pack.When the corroded battery was replaced, the device functioned as intended.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515047501 was not functioning as intended due to a corroded battery, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time.
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