Model Number EA323R |
Device Problem
Product Quality Problem (1506)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwath will be submitted.
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Event Description
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It was reported to aesculap ag that a purse string clamp 60mm jaw 280mm (part # ea323r) was used during a procedure performed on an unknown date.According to the complainant, the intestinal tissue crushed during surgery.The surgeon complained that he had so much tension that the intestinal tissue was no longer clamped, but was crushed.Additional information was received on february 3, 2022 which revealed that "during esophageal surgery, the esophagus slipped out of the clamp." this resulted in a procedureal delay of approximately fifteen (15) minutes.The complaint device was returned to the manufacturer for evaluation.The patient harm is currently unknown.The malfunction is filed under aag reference (b)(4).
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Event Description
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Clarification: the patient harm was updated to significant surgery delay.
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Manufacturer Narrative
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B5: surgical delay clarified.
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Manufacturer Narrative
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Additional information/correction: according to review of the investigation, this event is considered no longer reportable for the following reason: case was evaluated within product safety case (psc) due to contraindication.The failure mode risk analysis has been adjusted to 2(5).Investigation: visual investigation: here we detected that the product is in our specifications.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: there are no hints of a pre-damage or similar, products are according to the specifications valid at the time of production.According to the instructions for use (ifu), this product is not intended for use at the esophagus.Conclusion and measures / preventive measures: based upon the investigation results, a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results, a capa is not necessary.
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Search Alerts/Recalls
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