MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI VARIO; MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 6629321351

Device Problems Failure to Conduct (1114); Disconnection (1171); Electrical /Electronic Property Problem (1198)

Patient Problem No Code Available (3191)

Event Date 09/12/2015

Event Type  Injury  

Event Description

The healthcare provider initially reported the following: the light of the opmi vario microscope went out during a finger reconstruction surgery and the backup lamp did not work.The surgeon decided to finish the case without the microscope.No delay nor other problems were reported.The health care provider subsequently reported the following: the finger had to be amputated in second surgery due to poor connection of blood vessels and nerves.

Manufacturer Narrative

The manufacturer evaluated the illumination system and found that the connector between light power supply in the lamp housing and the insert-able lamp module carrier malfunctioned.One pin of the connector in the lamp housing was pushed back leading to a poor electrical connection.This caused higher electrical resistance and/or an electric arc resulting in oxidation of the pin over the time.As a result, the electrical connection got interrupted during the case, and none of both lamps was functioning.The most likely root cause that the pin was pushed back is an alignment issue of both connectors, when the lamp module carrier was inserted into the lamp housing.This could have caused mechanical force on the pin, and pushed it backwards.How to replace a lamp and insert the lamp module carrier into the lamp housing is described in the user manual, g-30-1607-en, page 22.The user manual also advises on page 174 about "like any technical device used in the or, this illumination may fail.It is thus recommended to have a suitable backup lamp, such as an or illuminator, ready at hand during surgery." it cannot be determined definitively, if the unsuccessful reconstruction of the finger was a result of the reported device problem, because there were also other factors like kind of amputation, time, state and condition of separated body limb, etc., playing an important role, and which are not known.(b)(4).

• Brand Name: OPMI VARIO
• Type of Device: MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 5164381
• MDR Text Key: 28798535
• Report Number: 9615010-2015-00011
• Device Sequence Number: 1
• Product Code: FSO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6629321351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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): Disability
• Patient Age: 37 YR
• Patient Weight: 70