|
Model Number C8XX2 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/21/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
|
|
Event Description
|
Procedure performed: laparoscopic hand assisted sigmoidectomy.Complaint 1 of 2: #2022-000889 (mfr # 2027111-2022-00542).Complaint 1 of 2: #2022-000890.Event description: "in both cases the gelport cap and attached alexis came out of the incision when the surgeon attempted to removed his hand through the cap.In the first case, this happened twice.In the second case, this happened once.There was no patient injury, current patient status unknown.Both cases continued with the same device.No other instruments were being used through the gel at the time of the event.The model of the gelport is c8xx2 (p/n 700314663), lot number 1433372.No product is available for return.Both gelports were brought in under a no charge scrub po." both cases were a laparoscopic hand assisted sigmoidectomy.Additional information received via email 25mar2022 from [name], associate clinical specialist: the products were disposed of before amr was made aware of the incidents.Alert date is 21mar2022.Products are not available for return.Patient status: there was no patient injury, current patient status unknown.Type of intervention: the case continued with the same device.
|
|
Manufacturer Narrative
|
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event.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: laparoscopic hand assisted sigmoidectomy.Complaint 1 of 2: #: (b)(4)- mfr# 2027111-2022-00542, complaint 1 of 2: #: (b)(4)- mfr# 2027111-2022-00551.Event description: "in both cases the gelport cap and attached alexis came out of the incision when the surgeon attempted to removed his hand through the cap.In the first case, this happened twice.In the second case, this happened once.There was no patient injury, current patient status unknown.Both cases continued with the same device.No other instruments were being used through the gel at the time of the event.The model of the gelport is c8xx2 (p/n: 700314663), lot number: 1433372.No product is available for return.Both gelports were brought in under a no charge scrub po." both cases were a laparoscopic hand assisted sigmoidectomy.Additional information received via email 25mar2022 from [name], associate clinical specialist: the products were disposed of before amr was made aware of the incidents.Alert date is 21mar2022.Additional information received via email 26apr2022 from [name], associate clinical development specialist: incision size for procedure was 8cm.Products are not available for return.Patient status: there was no patient injury, current patient status unknown.Type of intervention: the case continued with the same device.
|
|
Search Alerts/Recalls
|
|
|