MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL INC BEAVER-VISITEC INTERNATIONAL INC; 585159 HYDRODISSECTOR .50MM

Model Number	585159
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In reference to (b)(4), customer alleged that a surgeon was using a the cortical cleaving hydrodissector (bolger) 50x22mm, 25g x7/8 (33degree) by bvi visitec lot 3465442 exp 29/02/2028 ref 585159 during surgery.The device was in tact when opened and was used once and upon the second insertion to the eye the device was not connected leaving the metal part in-situ of the eye.The surgeon retrieved this with some forceps with no further complications.A new device of a different batch was then used with no problems.
Event or Problem Description
In reference to mhra report (b)(6) customer alleged that a surgeon was using a the cortical cleaving hydrodissector (bolger) 50x22mm, 25g x7/8 (33degree) by bvi visitec lot 3465442, exp 29/02/2028, ref 585159 during surgery.The device was in tact when opened and was used once and upon the second insertion to the eye the device was not connected leaving the metal part in-situ of the eye.The surgeon retrieved this with some forceps with no further complications.A new device of a different batch was then used with no problems.
Additional Manufacturer Narrative
Bvi quality assurance has followed its internal procedure to conduct the appropriate complaint investigation.The investigation includes a review of the procedure / training record and device history records, and no anomalies were found.All required elements of the dhr were appropriately filled; all manufacturing operations were recorded; all signatures and dates were present, and the lot passed required inspections.The risk assessment has been performed and due to the fact that this complaint appears to be single and isolated for the specific model we consider the occurrence as remote and the severity risk level is still adequate.

• Brand Name: BEAVER-VISITEC INTERNATIONAL INC
• Common Device Name: 585159 HYDRODISSECTOR .50MM
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL INC; 500 totten pond rd; 10 citypoint; waltham MA 02451 1916
• Manufacturer (Section G): BEAVER-VISITEC MEXICO; valle de los cedros; 1520; ciudad juarez, chihuahua 32575 ; MX 32575
• Manufacturer Contact: agnieszka drzewiecka ; 500 totten pond rd; 10 citypoint; waltham, MA 02451-1916 ; 8669068080
• MDR Report Key: 19210151
• Report Number: 1211998-2024-00009
• Device Sequence Number: 15184159
• Product Code: HMX
• UDI-Device Identifier: 00886158101987
• UDI-Public: 00886158101987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: 585159
• Device Lot Number: 3465442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown