Model Number C4130 |
Device Problems
Material Frayed (1262); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
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Event Description
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Procedure performed: lap gen surg.Event description: event 1 of 2: 2023-000613, event 2 of 2: 2023-000614.Event date unknown: in both procedures the devices were being used to move and manipulate internal organs.Both procedures where the devices failed were being used by different surgeon.One incident was 6/8 weeks ago and the other was 2 weeks ago.No changes in health resulting from the event.One procedure one of the pads fell off and was retrieved by the device itself.The other procedure the device pad/s started to fray and again was retrieved by the device.The frayed part is included in the grasper packaging.No details available on what other instruments were used when the complaint event occurred.Additional information received from applied medical representative via email 16mar2023: it is the representative's understanding that a whole pad came off and was retrieved.It was not with the device when it was given to the representative.Intervention: retrieved by the device.Patient status: zero issues.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the latis on one of the grasper pads was frayed.Based on the condition of the returned unit, the reported event likely occurred as a result of the usage of the grasper during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: section d4 (catalog number, lot number, udi number) and h4 is being updated as the incorrect product information was provided in the initial report.
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Event Description
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Procedure performed: lap gen surg event description: event 1 of 2: 2023-000613 [mfr #2027111-2023-00392] event 2 of 2: 2023-000614 [mfr #2027111-2023-00393] in both procedures the devices were being used to move and manipulate internal organs.Both procedures where the devices failed were being used by different surgeon.One incident was 6/8 weeks ago and the other was 2 weeks ago.No changes in health resulting from the event.One procedure one of the pads fell off and was retrieved by the device itself.The other procedure the device pad/s started to fray and again was retrieved by the device.The frayed part is included in the grasper packaging.No details available on what other instruments were used when the complaint event occurred.Additional information received from applied medical representative via email 16mar23: it is the representative's understanding that a whole pad came off and was retrieved.It was not with the device when it was given to the representative.Additional information received from iric in scotland 23mar23: the event happened on march 1, 2023.Applied medical 'pad' frayed during use on patient.Potential for frayed threads to get lost inside the patients abdomen.Possible cause - wear and tear/ faulty.Intervention: retrieved by the device patient status: zero issues.
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Search Alerts/Recalls
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