MAUDE Adverse Event Report: COOPERSURGICAL, INC. WALLACE RING PESSARY

Model Number WALLACE RING PESSAEY

Device Problems Difficult to Remove (1528); Output Problem (3005)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Report submitted by csi (b)(4) on behalf of end-user- incident detail- there is adhesion of ring pessary and unable to remove it from the patient even using a pessary cutter.The doctor tried to extract the pessary by pessary cutter, but in vain.The doctor is going to perform an additional surgical operation to extract the pessary with more invasive instruments.The pessary is still remained in the patient's body.The event is reportable in (b)(6).Wallace pessary ring.E-complaint (b)(4).

Event Description

Report submitted by csi japan on behalf of end-user- incident detail- there is adhesion of ring pessary and unable to remove it from the patient even using a pessary cutter.The doctor tried to extract the pessary by pessary cutter, but in vain.The doctor is going to perform an additional surgical operation to extract the pessary with more invasive instruments.The pessary is still remained in the patient's body.The event is reportable in japan.1216677-2021-00214 wallace pessary ring e-complaint (b)(4).

Manufacturer Narrative

Investigation x-no sample returned analysis and findings was the complaint confirmed? no.Distribution history the complainant did not report the part number (other than it is a wallace pessary) or lot number thus the distribution history cannot be obtained.Manufacturing record review a review of the device history record could not be performed because the part number and lot number were not provided.However, it should be noted at the time of manufacture, records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product part number and lot number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.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 of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: WALLACE RING PESSARY
• Type of Device: WALLACE RING PESSARY
• 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: 12576085
• MDR Text Key: 278171233
• Report Number: 1216677-2021-00214
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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 Number: WALLACE RING PESSAEY
• Device Catalogue Number: WALLACE RING PESSARY
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other