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Model Number 72403867 |
Device Problem
Sticking (1597)
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Patient Problem
Skin Tears (2516)
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Event Date 06/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is complete, a follow up report will be filed.(b)(4).Product was disposed by end user.
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Event Description
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(b)(4)."dr (b)(6) at (b)(6) used the penile elevation strap from the skw kit: (b)(4), for a penoscrotal ipp.During the use of the strap the skin was torn and had to be repaired surgically.Dr (b)(6) stated this had happened the last time he did an ipp too - i was not present for that case.But he had to repair that skin too." she stated that this injury occurred "during closing" and the patient is "just fine." she further stated that the doctor explained to her that "the strap is now sticky and grips the skin, and it rips.The doctor had to use one stitch to close the wound." this also occurred during the two previous surgeries with different patients.He feels like the strap is sticky now, and it used to not be sticky.
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Manufacturer Narrative
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Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is complete, a follow up report will be filed.Reference (b)(4).***update 07/05/2017*** *investigation no sample returned inspect stock product *analysis and findings: the reported event cannot be verified due to absence of 72403867 ams wilson kit lot number, or return product for investigation.However, if affected device is returned in the future and made available for root cause analysis, complaint may be reopened and addressed as needed.The complaint details mention that it was noticed the scroto support (p/n 720-285) was sticky compared to previous older parts.It is unconfirmed or unknown what sticky implies in terms of adhesion level, however, an inventory check of part both pre-sterilization and post sterilization was obtained to determine if parts were affected by eo sterilization, or time.Both samples did not exhibit any stickiness, nor are they any different from each other.The post-sterilization part was manufactured july 2011, while the pre-sterilization was manufactured july 2017.The units were manufactured 6 years apart, and did not have any apparent surface texture difference between them.It is unknown how the scrotol support p/n 720-285 was used or undergone other treatment prior to use and without part returned, a thorough investigation/root cause could not be performed.It is not clear how the issue occurred with the information present.*correction and/or corrective action corrective action is not warranted as the device was not returned for root cause investigation.Complaint will be monitored for trending.*corrective action level 4: none.Reason: complaint will be monitored to determine if there is any new trend for this complaint condition.*was the complaint confirmed? no.Product was disposed by end user.
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Event Description
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Reference (b)(4)."dr (b)(6) at (b)(6) medical center ((b)(6)) in (b)(6) used the penile elevation strap from the skw kit:72403867/(b)(4), for a penoscrotal ipp.During the use of the strap the skin was torn and had to be repaired surgically.Dr (b)(6) stated this had happened the last time he did an ipp too - i was not present for that case.But he had to repair that skin too." she stated that this injury occurred "during closing" and the patient is "just fine".She further stated that the doctor explained to her that "the strap is now sticky and grips the skin, and it rips.The doctor had to use one stitch to close the wound." this also occurred during the two previous surgeries with different patients.He feels like the strap is sticky now, and it used to not be sticky.
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Search Alerts/Recalls
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