MAUDE Adverse Event Report: COOPERSURGICAL, INC. ES-LNGR; SPOON FORCEPS LONG,SERRAT

Model Number ES-LNGR

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

G2: foreign: guatemala.Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a therapeutic hysteroscopy, the es-lngr forceps failed to open or close in the jaw, making it impossible for the doctor to remove the intrauterine device that the patient had lost.Patient was admitted in to the operating room.No patient injury.No additional information available.Es-lngr forceps: (b)(4).

Manufacturer Narrative

Distribution history: the complaint product was purchased from reda instrumente on 11/26/19 and sold between 1/24/20 - 4/30/20.Manufacturing record review: manufacturing record review not applicable to this product.Incoming inspection review: (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.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.(b)(4).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 : 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.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.If product returns, evaluation results will be recorded, and this complaint will be amended.

Event Description

No additional information is available.

• Brand Name: ES-LNGR
• Type of Device: SPOON FORCEPS LONG,SERRAT
• 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 drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 19097288
• MDR Text Key: 340809784
• Report Number: 1216677-2024-00016
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 888937025651
• UDI-Public: (01)888937025651
• Combination Product (y/n): N
• Reporter Country Code: GT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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
• Device Operator: Health Professional
• Device Model Number: ES-LNGR
• Device Catalogue Number: ES-LNGR
• Device Lot Number: 636139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female