MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 SOFT KOH-EFF; STERILE 3.5 SODT KOH-EFF

Model Number AD750SC-KE35

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per medwatch_uf_importer report # (b)(4)- device failed i.E.Broke, couldn't get it to work.Description of event- "uterine manipulator's plastic handle piece separated while surgeon was performing uterine manipulation.No patient injury occurred.Another uterine manipulator with the same lot# was opened.This one had no ref e-complaint-(b)(4).Sterile 3-5 soft koh-eff ad750-ke35 e-complaint-(b)(4).

Event Description

Per medwatch_uf_importer report (b)(4) device failed i.E.Broke, couldn't get it to work.Description of event- "uterine manipulator's plastic handle piece separated while surgeon was performing uterine manipulation.No patient injury occurred.Another uterine manipulator with the same lot# was opened.This one had no ref e-complaint (b)(4).1216677-2020-00194 sterile 3-5 soft koh-eff ad750-ke35 e-complaint (b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation x-review dhr x-inspect returned samples.Analysis and findings e-complaint (b)(4).Was the complaint confirmed? yes.Distribution history the complaint product was manufactured at csi on 02/24/20 under work order (b)(4).Manuf.Record review dhr - 285768 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 not show similar reported complaint conditions for this product size.However, on other sizes, there were similar complaints, though those complaints were not verified due to no product returned.Product receipt the complaint unit was returned.Visual eval.Visual examination of the complaint product confirms the complaint condition, where the two halves of the handle were separated.On closer examination, it appears that there was minimal glue on the gluing posts, which may have contributed to the halves coming apart.The pigtail assembly of the part was detached from the main tubing.It is unknown how the pigtail was detached from the tubing, as it is glued into the tube.Functional evaluation complaint product was functionally evaluated and found not to function properly.With the bottom handle split into two halves, the product was not functional.Root cause the root cause of this issue has been attributed to lower amount of glue inside of the gluing posts.The gluing operation is a manual process is done at the same time as the slider halves (which was glued correctly), and appears glue may not have been dispensed fully into the gluing posts for the main handle.This appears to be an isolated incident, however, a quality alert (qa-00242) was created and shared with manufacturing personnel of the complaint condition.Correction and/or corrective action quality alert was created to raise awareness of complaint issue.No further training required at this time.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: STERILE 3.5 SOFT KOH-EFF
• Type of Device: STERILE 3.5 SODT KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10476427
• MDR Text Key: 209031440
• Report Number: 1216677-2020-00194
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750SC-KE35
• Device Catalogue Number: AD750SC-KE35
• Device Lot Number: 285768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other