MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. RUGGLES MICRO DISSECTOR - ROUND - 7 1/2 INCHES -; N/A

Model Number RN6202

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

The facility reported that the suspected product will not be returned for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

The following was reported via medwatch mw5105526: ¿patient underwent surgery for removal of acoustic neuroma.During the resection of the tumor, the tip of the rhoton dissector broke off and went into the surgical field.After a ct determined the location of the tip.The patient returned to surgery on (b)(6) 2021 to remove the tip from the brain.Small metallic foreign body is noted intracranially in the region of the right cerebellopontine angle.Pathology comment after removal- consists of 0.2 cm in greatest dimension flattened somewhat ovoid portion of the metallic foreign material.¿ it was subsequently reported that following the event, the surgeons inspected the surgical field and did not find the broken piece.An intra-operative x-ray was performed, and the radiologist recommended a post-operative computerized tomography (ct) scan which then identified the missing piece.All parts were completely recovered in the 2nd surgery on (b)(6) 2021.It was reported that there was no surgical delay, and as of (b)(6) 2021, the patient was recovering at home due to her underlying reason for initial surgery.

Manufacturer Narrative

Rn6202 ruggles micro dissector - round was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information (m-1001) has been provided however, it is not a valid for integra instruments.Device history record cannot be performed at this time.However, a visual evaluation was performed per provided images; however, the tip of this rn6202 had broken off due to rough handling or environmental damage.The reported complaint is confirmed.

Event Description

N/a.

• Brand Name: RUGGLES MICRO DISSECTOR - ROUND - 7 1/2 INCHES -
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13609090
• MDR Text Key: 286228543
• Report Number: 3014334038-2022-00034
• Device Sequence Number: 1
• Product Code: GZX
• UDI-Device Identifier: 10381780458906
• UDI-Public: 10381780458906
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RN6202
• Device Catalogue Number: RN6202
• Device Lot Number: M-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2022
• 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 Sex: Female