MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 ULTEM KOH-EFF

Model Number AD750-KE35

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.

Event Description

Device would not slide when inserted into patient, another device had to be opened.No harm to patient.(b)(4).Sterile 3-5 ultem koh-eff ad750-ke35 (b)(4).

Event Description

Device would not slide when inserted into patient, another device had to be opened.No harm to patient.Ref: (b)(4).Sterile 3-5 ultem koh-eff ad750-ke35 (b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned.X-review dhr.Analysis and findings: distribution history: the complaint product was manufactured on 10/29/2018 under work order: (b)(4).Manuf.Record review: dhr: 259198 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service hist.Record: service history record not applicable to this product.Historical complaint review: a review of the 2-year complaint history did show similar reported complaint conditions, where the slider was not able to slide due to a bent rod.Product receipt: the complaint product has not been returned to coopersurgical.Product has been scrapped by customer.Visual eval: evaluation of the complaint product could not be completed as the complaint product has not been returned.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, the complaint similar to other complaints as mentioned earlier.Root cause: the root cause of this issue cannot be reliably determined based on the information provided.The product was discarded and was not available for root cause analysis.However, from looking at other returned complaint from the same product family but of different koh cup size the complaint condition is most likely due to the use of excessive force and/or improper handling by the end user.The use of excessive force would have subsequently bent the rod and not allowed the slider to move, as the curvature of the rod no longer conforms to the curvature of the slider handle.Was the complaint confirmed? no.Correction and/or corrective action none.Reason: the product met the required release specifications per dhr review.No re-training required.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: STERILE 3.5 ULTEM KOH-EFF
• Type of Device: STERILE 3.5 ULTEM KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10308834
• MDR Text Key: 203865321
• Report Number: 1216677-2020-00165
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K143650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 259198
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other