MAUDE Adverse Event Report: BAUSCH + LOMB STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER; INSTRUMENT, MICROSURGICAL

Model Number 20.04.25S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

The product has been returned but not yet evaluated.The investigation is ongoing.

Event Description

It was reported that two diamond dusted membrane scrapers broke during the same surgery.One broke at the tip but was not in the patient''s eye.The physician used a second one and the tip broke off at the insertion to the handle while in the patient''s eye.The physician used a mosquito clamp to pull the tip out of the trocar.An alcon 25g valve cannula was used.The incision was not enlarged.The 8-0 victyl suture required was part of the surgical protocol and not caused by the broken scraper.The surgeon finished the surgery with another scraper.There was no damage to the eye, complications or injuries to the patient.The patient is currently stable.

Manufacturer Narrative

Six original pouches of product 20.04.25s lot m0043022 were returned for evaluation.One pouch was opened and empty.Three pouches contained product and were sealed.Two pouches were opened and contained the products that are the subjects of this event.The first of these pouches contained the handle and the shaft of a 20.04.25s as separate pieces.The shaft had been broken off flush with the bushing that was pressed into the handle.The break point was jagged.One side of the shaft material showed evidence of stretching and the opposite showed bulging consistent with compression stresses.The probe appeared to have been exposed to radial stresses that exceeded the strength of the needle.Visual inspection showed no damage of abrasive tip at the distal end of the shaft.The second pouch contained the handle of a 20.04.25s without the shaft.The shaft had been broken off approximately 1/16 of an inch above the bushing.The short protrusion appeared slightly bent.The cross section was oval and showed evidence of bent and stretched similar to the other pouch.The probe appeared to have been exposed to radial stresses that exceeded the strength of the needle.Visual inspection showed no damage of abrasive tip at the distal end of the shaft.Evaluation of the returned sealed product failed to find any damage or anomaly that might contribute to breaks as demonstrated with the two subjected pouches returned.The exact cause of the reported event could not be determined.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is completed.

• Brand Name: STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER
• Type of Device: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): BAUSCH + LOMB; 3845 corporate centre dr.; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o''fallon MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15888360
• MDR Text Key: 307478039
• Report Number: 0001932402-2022-00004
• Device Sequence Number: 1
• Product Code: GZX
• UDI-Device Identifier: 20841305108848
• UDI-Public: (01)20841305108848(17)250601(10)M0043022
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20.04.25S
• Device Catalogue Number: 20.04.25S
• Device Lot Number: M0043022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT AND ACCESSORIES
• Patient Age: 72 YR
• Patient Sex: Female