APPLIED MEDICAL RESOURCES C0H11, KII DISSECTING BALLOON, OVL, 3/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number C0H11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Laceration(s) (1946)
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Event Date 02/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
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Event Description
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Procedure performed: laparoscopic inguinal hernia repair.Event description: rep was not present for the case.When the surgeon started to inflate the balloon he squeezed approximately 3-4 times and then heard a loud popping sound, the surgeon continued to try to inflate the balloon and when it would not inflate they removed it from the patient.When the dissecting balloon was removed, they noticed a hole in the balloon.The surgeon did try to reposition the balloon before removing it from the patient.Upon inspection of the patient they noticed fluid in the abdomen which they determined came from the patient's bladder where they found a tear.The bladder tear was repaired without issue and a new dissecting balloon was used to complete the procedure without issue.The surgeon does not know whether the balloon caused the tear or if it was caused when creating the incision, the patient is a young male and may not have emptied his bladder before the procedure causing a small working space for the surgeon to insert the balloon.It is unknown if the patient had any previous surgeries.Per the rep there was no balloon particulation.Product available for return.Intervention: tear was repaired and a new dissecting balloon was used to complete the procedure.Patient status: there was a tear in the patient's bladder which has been repaired, patient is doing good.
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Event Description
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Procedure performed: laparoscopic inguinal hernia repair.Event description: rep was not present for the case.When the surgeon started to inflate the balloon he squeezed approximately 3-4 times and then heard a loud popping sound, the surgeon continued to try to inflate the balloon and when it would not inflate they removed it from the patient.When the dissecting balloon was removed, they noticed a hole in the balloon.The surgeon did try to reposition the balloon before removing it from the patient.Upon inspection of the patient they noticed fluid in the abdomen which they determined came from the patient's bladder where they found a tear.The bladder tear was repaired without issue and a new dissecting balloon was used to complete the procedure without issue.The surgeon does not know whether the balloon caused the tear or if it was caused when creating the incision, the patient is a young male and may not have emptied his bladder before the procedure causing a small working space for the surgeon to insert the balloon.It is unknown if the patient had any previous surgeries.Per the rep there was no balloon particulation.Product available for return.Additional information was received via email on 02mar2022 from applied medical representative: "when they were initially inflating the balloon the first time (3-4 pumps) they noticed more fluid in the cavity than normal- with the balloon in the abdomen.The patient was a young male and the working space is usually small for adult males, but even smaller for young males, especially when they have a tight abdomen like this patient." the patient did not have any previous surgeries.Per the rep, "i don¿t think [the surgeon] repositioned the balloon before removing it the first time, once it popped he moved it a little bit to keep inflating and that¿s when he realized it wasn¿t expanding so they removed it and saw the hole.Then they opened a new unit and placed it in the same cavity and kept inflating." a 10 mm [device name] scope was used at 0 degrees.Intervention: tear was repaired and a new dissecting balloon was used to complete the procedure.Patient status: there was a tear in the patient's bladder which has been repaired, patient is doing good.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a hole in the balloon.The balloon material near the tear was stretched.Based on the condition of the returned unit, it is likely that the balloon stretched and tore due to excessive force exerted on the material.However, the exact root cause of bladder tear could not be determined.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the exact root cause of the injury.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
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