APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
|
Back to Search Results |
|
Model Number CTB03 |
Device Problem
Dull, Blunt (2407)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/28/2021 |
Event Type
malfunction
|
Event Description
|
Procedure performed: appendectomy.Event description: two complaints have been made from this submission."the quality assurance coordinator describes as an action not satisfactory as follow: 'two trocars are opened for surgery, the surgeon, when trying to occupy supplies, comments that the first trocar has no edge, the second trocar is delivered and repeats the same' " product available for return.Additional information received via email on 02mar2022 from applied medical representative: "confirm that the patient had no problem" additional information received via email on 07mar2022 from applied medical representative: the complaint the facility submitted is that the blade was dull.Patient status: confirm that the patient had no problem.
|
|
Manufacturer Narrative
|
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
|
|
Manufacturer Narrative
|
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit.However, the complainant¿s experience could not be replicated or confirmed as the returned unit performed as intended.The returned unit met specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
|
|
Event Description
|
Procedure performed: appendectomy.Event description: two complaints have been made from this submission.Complaint # (b)(4) [mfr report # 2027111 - 2022 - 00458].Complaint # (b)(4) [mfr report # 2027111 - 2022 - 00459]."the quality assurance coordinator describes as an action not satisfactory as follow: two trocars are opened for surgery, the surgeon, when trying to occupy supplies, comments that the first trocar has no edge, the second trocar is delivered and repeats the same." product available for return.Additional information received via email on 02mar2022 from applied medical representative: "confirm that the patient had no problem".Additional information received via email on 07mar2022 from applied medical representative: the complaint the facility submitted is that the blade was dull.Patient status: confirm that the patient had no problem.
|
|
Search Alerts/Recalls
|
|
|