ENDO DISSECT
Received Apr 17, 2019 · Event occurred Mar 21, 2019
Report 2647580-2019-02062 · MDR key 8524027
Device
Generic name
Motor, Surgical Instrument, Pneumatic Powered
Manufacturer
Us Surgical Puerto RicoModel number
176645Catalog number
176645
Lot number
P7J1325X
Product problems
- Failure to Align
- Failure to Align
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION NOTED THAT THE JAWS WERE SLIGHTLY MISALIGNED. ALTHOUGH A SLIGHT MISALIGNMENT WAS FOUND ON RECEIVED INSTRUMENT, IT WAS TESTED BY ENGINEERING AND COMPLIED PER MANUFACTURING SOP TO BE LESS THAN 0.020¿. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC SURGERY, AT THE TIME OF UNLOCKING THE DEVICE, IT WAS EVIDENT THAT THE BITE WAS NOT UNIFORM. THE JAWS DID NOT CLOSE IN A GOOD WAY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF ONE DEVICE. EVALUATION OF THE PHOTO NOTED A POTENTIAL JAW MISALIGNMENT. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC SURGERY, AT THE TIME OF UNLOCKING THE DEVICE, IT WAS EVIDENT THAT THE BITE WAS NOT UNIFORM. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.