MAUDE Adverse Event Report: BAUSCH + LOMB KOCH MANIPULATOR STERILE; HANDHELD SURGICAL INSTRUMENT

Model Number	E0713 G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is ongoing.
Event or Problem Description
The user facility in germany reported the tip of the chopper broke and entered the patient's eye.This piece was removed with a forceps.There was no patient impact, and no additional anesthesia required.
Additional Manufacturer Narrative
A photo as well as a video was provided by the customer.Based on the photo and video, the reported problem was duplicated, and the damage was confirmed.The tip of the manipulator broke off.However, the sample (1x e0713 g reusable koch stop & chop manipulator from lot no.2267843) was returned for investigation.The broken off tip of the manipulator was not returned.The parameters of the hcf¿s reprocessing process were not communicated and are unknown.Visual inspection under a microscope revealed that the tip had broken off at the exact point where the greatest tensile stress occurred.It is very likely that there was already a small crack at this point.The ultrasound device then caused it to break off at exactly this point.Device history of lot no.2267843 was reviewed; no deviations or issues were detected.The lot was manufactured according to specification.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: KOCH MANIPULATOR STERILE
• Common Device Name: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB GMBH; lilienthalstr.16.18; eppelheim 69214 ; GM 69214
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23037100
• Report Number: 0001920664-2025-00102
• Device Sequence Number: 9454991
• Product Code: HNN
• UDI-Device Identifier: 04058935005108
• UDI-Public: (01)04058935005108(10)2267843
• Combination Product (Y/N): N
• PMA/510(K) Number: K073023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: E0713 G
• Device Lot Number: 2267843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown