APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CD003 |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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No product is being 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 appendectomy.Event description: complaint 1 of 2: (b)(4), mfr# 2027111 2023 00331.Complaint 2 of 2: (b)(4).Additional information provided via email from [facility] on 10 january 2023: the error occurred on three occasions, on (b)(6) 2023, and (b)(6) 2023.Device was used in laparoscopic appendicectomy.The item was used on the patient no injury to the patient.After inserting the bag inside, push the handle to open bag the metal part was got deployed.The user is an experienced person, hopes it is not a human error.The following information was received on 11 january 2023 via email as part of the response for the request for additional information for complaint (b)(4): 4th january ¿ the incident reported last week took place, but the device had been inserted into the patient as reported later (not just opened in sterile field).A second device (lot number unknown) was also opened after the first incident and had the same issue.They have not reported the second device as an incident internally.The product in each instance was confirmed as being intact on removal from the packaging and had been inserted into the trocar and deployed by the surgeon.This is when the bag released from the metal prongs prior to the specimen being inserted.Additional information provided via email from [name] on 12 january 2023: yes, this ¿second device (lot unknown)¿ opened and used in the event on (b)(6) 2023.She didn¿t comment on why they didn¿t create a second incident report for the 4th january.They were able to use a manual instrument to put the specimen into the bag and retrieve it this way.This was also the method they used to retrieve the specimen on the 9th when they had a repeat of the device incident.Intervention: they were able to use a manual instrument to put the specimen into the bag and retrieve it this way.Patient status: patient was unaffected.
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Manufacturer Narrative
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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 of the tissue bag falling off the supports.Based on previous similar events, the likely root cause of the reported event is retraction prior to full deployment of the tissue bag.The instructions for use (ifu) states, "hold the inzii retrieval system in an upright position and push the thumb ring forward to deploy and advance the rim of the bag into the body cavity.The thumb ring must be pushed completely forward until it has reached its advancing endpoint, which is indicated by a stop.Do not retract prior to full deployment.".
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Event Description
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Procedure performed: lap appendectomy.Event description: complaint 1 of 4: (b)(4), mfr# 2027111 2023 00331, complaint 2 of 4: (b)(4), mfr# 2027111 2023 00335, complaint 3 of 4: (b)(4), mfr# 2027111 2023 00333, complaint 4 of 4: (b)(4), mfr# 2027111 2023 00334.Additional information provided via email from [facility] on 10 january 2023: the error occurred on three occasions, on (b)(6) 2023, and (b)(6) 2023.Device was used in laparoscopic appendicectomy.The item was used on the patient no injury to the patient.After inserting the bag inside, push the handle to open bag the metal part was got deployed.The user is an experienced person, hopes it is not a human error.The following information was received on 11 january 2023 via email as part of the response for the request for additional information for complaint (b)(4): (b)(6) ¿ the incident reported last week took place, but the device had been inserted into the patient as reported later (not just opened in sterile field).A second device (lot number unknown) was also opened after the first incident and had the same issue.They have not reported the second device as an incident internally.The product in each instance was confirmed as being intact on removal from the packaging and had been inserted into the trocar and deployed by the surgeon.This is when the bag released from the metal prongs prior to the specimen being inserted.Additional information provided via email from [name] on 12 january 2023: yes, this 'second device (lot unknown)' opened and used in the event on 4 january 2023.She didn¿t comment on why they didn¿t create a second incident report for the (b)(6).They were able to use a manual instrument to put the specimen into the bag and retrieve it this way.This was also the method they used to retrieve the specimen on the 9th when they had a repeat of the device incident.Intervention: they were able to use a manual instrument to put the specimen into the bag and retrieve it this way.Patient status: patient was unaffected.
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Search Alerts/Recalls
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