MAUDE Adverse Event Report: COOPERSURGICAL, INC. M-SELECT MUSHROOM

Model Number	10137
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported condition.
Event or Problem Description
Cup split at site where it meets the connection tubing".Further details - m-select mushroom vacuum-assist delivery cup applied at the flexion point below the posterior fontanelle.Position checked and pressure increased to 20 cmhg.Application rechecked and pressure increased to 80 cmhg.Gentle traction was applied and baby's head rotated.Cup detached after the second pull and loss of suction noted during that pull.Cup reattached and position of cup rechecked.Air leak heard and lack of adequate suction noted by the registrar conducting the delivery.Cup removed and split seen by the registrar.Ref: e-complaint (b)(4).
Event or Problem Description
Report stated " cup split at site where it meets the connection tubing".Further details - m-select mushroom vacuum-assist delivery cup applied at the flexion point below the posterior fontanelle.Position checked and pressure increased to 20 cmhg.Application rechecked and pressure increased to 80 cmhg.Gentle traction was applied and baby's head rotated.Cup detached after the second pull and loss of suction noted during that pull.Cup reattached and position of cup rechecked.Air leak heard and lack of adequate suction noted by the registrar conducting the delivery.Cup removed and split seen by the registrar.1216677-2019-00312-1 m-select mushroom 10137 (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation: review dhr.Inspect returned samples.Analysis and findings: manufacturing record review.Dhr-10137-245713 was reviewed and no non-conformities, related to the complaint condition, were noted.The product was manufactured starting 9/18/2018 and completed 10/03/2018.Incoming inspection review.Incoming inspection record review of the cup and disk, m-select to this product was performed, c of c is attached.Service history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history showed similar reported complaint conditions.All similar reported complaints for which product was returned were attributed to use contraindicated in csi ifu for instruction use.Product receipt.The product was returned, and the reported event result was confirmed, refer to attached photos.There were six additional m-select devices returned that were still pouched and unused.Visual evaluation.Evaluation of the complaint was performed on the six additional devices that were returned along with the affected device sited in the complaint.The affected device was confirmed as being damaged and the additional six devices confirmed as acceptable.Functional evaluation evaluation of the complaint was performed on the six additional devices that were returned along with the affected device sited in the complaint.The reported and confirmed event could not be replicated even when the device vacuum cup and stem were severely manipulated, refer to attached photos.Root cause.Root cause for the result of the reported event is considered indeterminable, however, contra-indicated use is likely.Corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*was the complaint confirmed? yes.

• Brand Name: M-SELECT MUSHROOM
• Common Device Name: M-SELECT MUSHROOM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 9437079
• Report Number: 1216677-2019-00312
• Device Sequence Number: 2535688
• Product Code: HDB
• UDI-Device Identifier: 00888937003093
• UDI-Public: 888937003093
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K890307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: 10137
• Device Catalogue Number: 10137
• Device Lot Number: 245713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown