ETHICON ENDO-SURGERY, LLC. OPT BLUNT TIP 12X100 SMOOTH; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
|
Back to Search Results |
|
Catalog Number 2H12LP |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/16/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Date sent: 2/12/2024.D4: batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
It was reported that during a low anterior resection, the inner cylinder could not be removed from the outer seal.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
|
|
Manufacturer Narrative
|
Pc-(b)(4) date sent: 3/19/2024 d4: batch # a9e34w investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 2h12lp device was returned with the obturator inserted thought the sleeve and with no apparent damage.In addition, the tyvek was returned along with the instrument.The obturator was unlatch from the universal seal without any anomalies noted.The device was visually inspected and no damaged found on the seals.The device was fully functional according to the manufacturing requirements.The event described could not be confirmed as the device was returned without any damaged.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
|
|
Search Alerts/Recalls
|
|
|