MAUDE Adverse Event Report: COOPERSURGICAL, INC. SHAATZ PESS 2-1/4

Model Number MXPSH2-1/4

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).

Event Description

Report stated - "issue with each of them pertaining to texture (to hard), color, stiffness, ease of use.The customer has had ongoing issue with the listed pessaries not being able to insert." (b)(4).Shaatz pessary 2-1 4 mxpsh2-1 4.

Manufacturer Narrative

*investigation.X-initiated manufacturer's investigation.X-review dhr.X-inspect stock product.*analysis and findings.Distribution history.The complaint product was manufactured at csi in march 2019 under work order (b)(4).Manufacturing record review.Dhr19mpg002153 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 history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history did show one other complaint for this issue.Visual evaluation/functional evaluation.Evaluation of the complaint product could not be completed as it could not be located at this time.If the product should be located at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause.The shaatz pessary is molded at csi as a gellhorn pessary.A secondary operation removes the stem to make it a shaatz pessary.Quality engineering, manufacturing, marketing, and product surveillance conducted an investigation into the recent complaints regarding the hardness and rigidity of the pessary product line.There have been no specification changes in the last 2 years.Returned product from historical complaint investigations and sample product from finished goods inventory were evaluated and the reported condition could not be duplicated.The products were found to meet all approved release specifications.It should be noted that this product was originally manufactured for coopersurgical by a supplier (eis) until mid-2017.Manufacturing was moved to coopersurgical and validated in november 2017 (val-16-0219) using a new silicone supplier.It is suspected the customer noticed the current production pessary was slightly harder than the previously received supplier pessary.It should also be noted that the current silicone supplier provides certifications on every shipment with durometer hardness testing per astm d2240 which verifies durometer specifications are met.Based upon an analysis of historical returned/complaint product, stock product, dhr review and certificates of conformance, the reported complaint condition could not be confirmed.*correction and/or corrective action /*preventative action activity.Capa 735 has been opened to determine if customer observations with regard to pessary durometer warrant further product enhancements.

Event Description

Report stated - "issue with each of them pertaining to texture (to hard), color, stiffness, ease of use.The customer has had ongoing issue with the listed pessaries not being able to insert.".Ref e-complaint (b)(4).1216677-2020-00117 shaatz pessary 2-1 4 mxpsh2-1 4 e-complaint-(b)(4).

• Brand Name: SHAATZ PESS 2-1/4
• Type of Device: SHAATZ PESS 2-1/4
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct
• MDR Report Key: 10002260
• MDR Text Key: 194943882
• Report Number: 1216677-2020-00117
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

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: MXPSH2-1/4
• Device Catalogue Number: MXPSH2-1/4
• Device Lot Number: 261568
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other