MAUDE Adverse Event Report: BAUSCH + LOMB MCELVEEN HITSELBERGER DISSECTOR; HANDHELD SURGICAL INSTRUMENT

Model Number N1706

Device Problem Break (1069)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

This investigation is on going.

Event Description

It was reported by the user facility in canada that the surgeon used the hitselberger instrument as intended, and the tip broke off into the patient.The instrument piece was not retained in the patient.There was increased operative time and exposure to x-ray when searching for the broken piece.The instrument was retained for evaluation.

Manufacturer Narrative

The product has been requested but not yet received.Since the instrument is not lot controlled and has not returned for evaluation, no device history report can be performed.As the device has not yet returned for evaluation, a root cause into the complaint could not be established.Although we are unable to determine the root cause without the product one possible cause for this type of issue is the use of excessive force.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is underway.

Manufacturer Narrative

Visual inspection of the returned product found that there were slight marks at the distal end of the instrument indicating the instrument was subjected to some type of force.This dissector is intended to be used in the ear canal, not for a suboccipital craniectomy.The surgeon was performing a suboccipital craniectomy which the instrument is not designed for.The root cause is unknown, possible user error.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: MCELVEEN HITSELBERGER DISSECTOR
• Type of Device: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17212509
• MDR Text Key: 317968482
• Report Number: 0001920664-2023-70061
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N1706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1