MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M320 W12; SURGICAL MICROSCOPE

Model Number M320 W12

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.

Event Description

Leica microsystems (schweiz) ag received a complaint from norway stating that the m320 optics carrier became loose during a procedure.There was no patient or user injury.

Manufacturer Narrative

This is a final report.The investigation determined that the cause of the incident was improper assembly of the retaining ring on the microscope adapter bolt during manufacturing.Furthermore it was found that an incorrect retaining ring was installed which was not sized to specification, therefore it slipped out when rotated under load.Countermeasures at the supplier: implement test step in the final inspection "rotational movement with weight".Use installation tools (pliers) with an opening lock.Change purchasing from bulk to tightly welded bundles.A review of the complaint database revealed that there are no similar or identical complaints.Improper assembly along with an incorrect retaining ring is considered an isolated failure with no design issue and no indication of an adverse trend.The defective swing arm was replaced by a new one.

• Brand Name: LEICA M320 W12
• Type of Device: SURGICAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• Manufacturer (Section G): LEICA INSTRUMENTS (SINGAPORE) PTE LTD; 12 teban gardens crescent; singapore, 60892 4; SN 608924
• Manufacturer Contact: roland jehle ; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• MDR Report Key: 14753768
• MDR Text Key: 302700260
• Report Number: 3003974370-2022-00011
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M320 W12
• Device Catalogue Number: 10449125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1