MAUDE Adverse Event Report: GYRUS ACMI, INC ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE; STONE RETRIEVAL BASKET

Model Number NT4W22115

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced device and original packaging was returned to olympus for evaluation.The evaluation confirmed the original (outer) box was severely crushed and opened as its seal was torn off.The (inner) packing tray containing the device inside is also crushed with multiple dents on the edge of the package, likely causing the packaging tray seal label to lift up and become slightly open; therefore, the sterile barrier was breached.The device appeared to be intact, and in new condition.Based on the evaluation, the reported event is likely due to improper handling from excessive force applied during transit or storage.The dhr review for this device was conducted.All records indicate that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

Event Description

Olympus was informed that upon receipt of the device the device packaging was observed to be heavily damaged and the unit was unusable.There was no patient involvement.It was not specified if the sterile packaging of the device had been breached.

• Brand Name: ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL BASKET
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8324279
• MDR Text Key: 138540164
• Report Number: 2951238-2019-00428
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2019

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: No Information
• Device Model Number: NT4W22115
• Device Lot Number: MK803710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1