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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL INC. 5MM 2-HUNT SEC CANN/PYRA
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COOPERSURGICAL INC. 5MM 2-HUNT SEC CANN/PYRA Back to Search Results
Model Number 900-820
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
 
Event Description
"the apple trocar (900-820) was chipped off after introducing it into the abdomen.Usage was as per usual and informed.Doctor had to remove the chip off from patient.Causing additional time and cost for patient.At risk of losing the foreign body." (b)(4).
 
Manufacturer Narrative
Reference (b)(4).Investigation: initiated manufacturer's investigation, no sample returned, review dhr.Analysis and findings: a dhr review was not possible as the lot number was not provided for review.The complaint condition will be confirmed based on the pictures provided, however, a root cause analysis is not currently possible without the unit.It is mentioned in the complaint that the unit was discarded by customer after the surgical procedure.Should the unit arrive in the future, any pertinent information will be added to the complaint file.A 2 year complaint history for the product was reviewed and there were no other occurrences for any broken cannula.During review of previous complaints within the same product family, a complaint (b)(4) for a broken cannula was found for p/n 900-846.However, for complaint (b)(4), it was apparent that the tray was crushed, causing the cannula to break and was deemed not a manufacturing issue.Unit was not returned for investigation, therefore the root cause cannot be determined.Although a dhr review was no possible, a shipment report was generated that lists previously shipped p/n 900-820 to the customer.The three most recent dhrs were reviewed (dhrs pertaining to lots 239629, 246809, 230400) and found that there were no non-conformances that relate to the complaint condition of a broken/deficient cannula.Correction and/or corrective action: no product was returned for root cause analysis.If product is returned in the future, pertinent information will be added to the complaint file.Complaint condition will be monitored for trending.None reason: per the ufmea ((b)(4)) the rpn number associated with balloon breakage is at 72, and is not subject to further review and analysis per sop-eng-322.No product returned for analysis.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
 
Event Description
"the apple trocar (900-820) was chipped off after introducing it into the abdomen.Usage was as per usual and informed.Doctor had to remove the chip off from patient.Causing additional time and cost for patient.At risk of losing the foreign body." ref (b)(4).
 
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Brand Name
5MM 2-HUNT SEC CANN/PYRA
Type of Device
5MM 2-HUNT SEC CANN/PYRA
Manufacturer (Section D)
COOPERSURGICAL INC.
95 corporate drive
trumbull 06611
MDR Report Key8312387
MDR Text Key135523414
Report Number1216677-2019-00028
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
PMA/PMN Number
K911462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 12/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number900-820
Device Catalogue Number900-820
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/18/2019
Initial Date FDA Received02/06/2019
Supplement Dates Manufacturer Received01/18/2019
Supplement Dates FDA Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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