MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI PICO ON S100 FLOOR STAND; MICROSCOPE, SURGICAL GENERAL&PLASTIC

Catalog Number 000000-1095-102

Device Problems Fluid/Blood Leak (1250); Failure To Service (1563)

Patient Problem Abrasion (1689)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Narrative: zeiss records indicate that there is no service contract or service history for the microscope in question.The hcp confirmed that the last service was done more than 7 years ago.A field service engineer performed an on-site inspection of the microscope and found that the pneumatic spring was leaking and did not hold position.The user manual g-30-1385-en, issue 5.0, printed on 14.05.2001, advises on several pages to contact service, if a function of the microscope fails, e.G.Page 16, 38, 42.The user manual informs about a regular maintenance interval of every 24 months for the suspension system.The manufacturer's conclusion is that normal use and normal maintenance and repair following zeiss procedures could not lead to the occurred scope arm drop.The user manual advises on page 103 to perform a detailed function check before surgery and without patient present.This contains under title "setting the suspension arm weight compensation" also the proper balancing of the microscope.

Event Description

The healthcare professional (hcp) reported the opmi pico microscope arm was in the upper standby position when dropping suddenly about two feet.The scope head hit the patient above the left eyebrow.The hcp described the resulting abrasion as "superficial" and confirmed that no medical intervention was needed.The scope was used for routine examination of patient's ears.The examination was completed successfully.

• Brand Name: OPMI PICO ON S100 FLOOR STAND
• Type of Device: MICROSCOPE, SURGICAL GENERAL&PLASTIC
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 5842182
• MDR Text Key: 51004062
• Report Number: 9615010-2016-00012
• Device Sequence Number: 1
• Product Code: FSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1095-102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 95