MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 4.0 ULTEM KOH-EFF

Model Number AD750-KE40

Device Problems Material Rupture (1546); Material Perforation (2205)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report submitted by csi rep.Incident details surrounding event.Dr (b)(6) inserted delineator into the patient, and injected 30cc air into the tip balloon.Once above, it was noticed that the manipulator had perforated the uterus, and that the intra uterine balloon had ruptured.Their concern was that there could be fragments left in the abdominal cavity.They examined the balloon at the end of the case and felt that there could be a fragment still in the patients abdominal cavity.They looked around but were unable to see or retrieve any balloon fragments.Their main concern is that if a fragment is left behind, could it cause problems.(b)(4).Sterile 4-0 ultem koh-eff ad750-ke40 (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 08/30/19 under work order (b)(4).Manuf.Record review dhr - 274803 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 one similar reported complaint conditions.Product receipt the complaint product was returned.Visual eval.Evaluation of the complaint product revealed a broken distal balloon that appears to have broken during use.This indicates that the balloon was in working condition and may have encountered a sharp object during use.Functional evaluation of the complaint product revealed that the distal balloon was not working.Root cause the root cause of this issue has been attributed to the distal balloon of the device coming into contact with a sharp object during use.During manufacture of the device, the distal balloon is checked for gross leak, and a cut such as that found on the returned device would have been rejected.Therefore, the root cause of the leak on the distal balloon is not considered to be a manufacturing issue.Correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report submitted by csi rep.Incident details surrounding event.Dr macedonia inserted delineator into the patient, and injected 30cc air into the tip balloon.Once above, it was noticed that the manipulator had perforated the uterus, and that the intra uterine balloon had ruptured.Their concern was that there could be fragments left in the abdominal cavity.They examined the balloon at the end of the case and felt that there could be a fragment still in the patients abdominal cavity.They looked around but were unable to see or retrieve any balloon fragments.Their main concern is that if a fragment is left behind, could it cause problems.Ref e-complaint (b)(4).1216677-2020-00246 sterile 4-0 ultem koh-eff ad750-ke40 e-complaint (b)(4).

• Brand Name: STERILE 4.0 ULTEM KOH-EFF
• Type of Device: STERILE 4.0 ULTEM 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: 10729530
• MDR Text Key: 249924457
• Report Number: 1216677-2020-00246
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143560
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750-KE40
• Device Catalogue Number: AD750-KE40
• Device Lot Number: 274803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: No
• 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