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

Model Number	10137
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report stated "the suction cup cracked during use".Per additional information- the suction cup ref 199 07 01 cracked during a delivery and she had to use another suction cup".End-user further stated- "the pharmacist calls, she explains me that she had sent a declaration of a case of materialovigilance, concerning an obstetrical suction cup to the e-mail address (contact ccd) on 08/03 but that she did not have any return since.This concerns a vacuum cup that melted when used during the delivery.The vacuum could not be done.The staff had changed the suction cup.The suction cup concerned is at the pharmacy, if the laboratory wishes to recover it.The pharmacist would like to have an exchange.No direct impact on the patient, just a delay in management.M-select mushroom 10137.E-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation no sample returned.*analysis and findings distribution history the complaint product was manufactured at csi, but the lot number was not provided.Thus, the date of manufacture is not available.Manufacturing record review a review of the device history record could not be performed because the lot number was 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 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 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.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 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? no.
Event or Problem Description
Report stated "the suction cup cracked during use".Per additional information- the suction cup ref 199 07 01 cracked during a delivery and she had to use another suction cup".End-user further stated- "the pharmacist calls, she explains me that she had sent a declaration of a case of materialovigilance, concerning an obstetrical suction cup to the e-mail address (contact ccd) on 08/03 but that she did not have any return since.This concerns a vacuum cup that melted when used during the delivery.The vacuum could not be done.The staff had changed the suction cup.The suction cup concerned is at the pharmacy, if the laboratory wishes to recover it.The pharmacist would like to have an exchange.No direct impact on the patient, just a delay in management.M-select mushroom 10137 (b)(4).

• 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: 11791577
• Report Number: 1216677-2021-00087
• Device Sequence Number: 13683376
• Product Code: HDB
• UDI-Device Identifier: 00888937003093
• UDI-Public: 888937003093
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/16/2023

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 Model Number: 10137
• Device Catalogue Number: 10137
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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